Product Recall

Definition

Product recall is a process taken by the manufacturer, importer and wholesaler to remove or withdraw a particular products from all links of distribution.

The removal or withdrawal may be due to critical quality defects discovered or serious adverse drug reactions reported which might cause health risks to users of the products.

Decision For Recall

The decision for recall shall be made when there is or may caused potential risk to the user of the products by reason of faulty production or on medical grounds:

a) Voluntarily undertaken by the manufacturers and distributors.

b) As directed by the Director of Pharmaceutical Services, Ministry of Health.

Unless the Director of Pharmaceutical Services, Ministry of Health has already specified the degree and level of a particular products recall, the degree and level will be decided by the company’s Product Recall Committee based on risks involved. The Product Recall Committee shall comprise of personnel who are responsible for the execution and coordination of recall. The persons responsible shall handle all aspects of the recalls with the appropriate degree of urgency.

No recall shall take place without first consulting/informing the Authority.

Recalls that involve specific batch will not involve any other batch/batches that currently available in the market.

Not all recalls are initiated because a product is deemed unsafe or ineffective. A recall may also be conducted to remove products from the Malaysian market with quality defects that do not affect their safety and efficacy.

Degree of Recall

The degree of recall is classified according to the severity of quality defects and adverse reactions of the products.

Degree	Definition	Recall Notice by PRH
I	Products with major health risks that might cause serious injuries or death. Should be under an embargo within 24 hours	Within 24 hours of recall commencement or directive
II	Products with minor health risks or are substandard. Should be under an embargo within 72 hours	Within 48 hours of recall commencement or directive
III	Products with other reasons for recall that can cause health risks to users. Should be under an embargo within 30 days or as specified	Within 72 hours of recall commencement or directive

Level of Recall

The level of recall depends on the nature of problem, extent of the product’s distribution and degree of hazard involved.

Level A: To all consumers (end users).

Level B: To all points of sales (e.g. Hospitals, Pharmacies, Clinics, Specialist Centres).

Level C: To all sub-distributors (wholesalers).

Public Notification

Not all recalls are announced in press releases. However, when a product that has been widely distributed or poses a serious health hazard is recalled, NPRA may do so if the agency determines it is necessary to protect consumers.

References:

1) Drug Registration Guidance Document (DRGD)

2) Guideline on Good Distribution Practice

Products as listed below have been recalled from the market.

Year 2024

No	Product Name	Registration Number	Active Ingredients	Batch Number	Reason for Recall	Degree and Level of Recall	Registration Holder	Date of Recall
1	Axcel Cimetidine-200 Suspension	MAL19940272AZ	Cimetidine 200mg/5ml	B2305045	The assay of cimetidine and preservative sodium benzoate conducted on batch B2305045 with pack size 100mL was found to be out of specifications during real time stability study at 3 and 6 months point	Voluntary recall at the point of sales	Kotra Pharma (M) Sdn Bhd, Malaysia	23 January 2024
2	Tenormin Tablet 50mg	MAL19870055ACZ	Atenolol 50mg	6004731	label incompliance	Voluntary recall at the point of sales	DKSH Malaysia Sdn Bhd, Malaysia	01 February 2024
3	Herbanika Barut	MAL20014435T	Herbs	2211351	The batch tested by NPRA found to contain Total Aerobic Microbial Count and Total Yeasts and Moulds Count above allowable limit	Degree III recall at the point of sales	MISB Resources Sdn Bhd,Malaysia	01 February 2024
4	Ubijaga Tongkat Ali Plus	MAL06021354T	Herbs	T354UT30	The batch tested by NPRA found to contain Total Aerobic Microbial Count and Bile-Tolerant Gram Negative Bacteria above allowable limit	Degree III recall at the point of sales	Syarikat Zulkifli Bamadhaj, Malaysia	01 February 2024
5	Kapsul Habbatus Sauda 300mg	MAL06051554T	Semen Nigella sativa 300mg	T308KHS	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall at the point of sales	Syarikat Zulkifli Bamadhaj,Malaysia	01 February 2024
6	Vigouroxy	MAL06091569T	Herbs	052205V	The batch tested by NPRA found to contain Bile-Tolerant Gram Negative Bacteria above allowable limit	Degree III recall at the point of sales	Nature's Grace (M) Sdn Bhd, Malaysia	01 February 2024
7	Apo-Mometasone Furoate Aqueous Nasal Spray 50 MCG/Metered Spray	MAL18016032AZ	Mometasone furoate 50mcg/ metered spray	TZ2389	Potential presence of Burkholderia cepacia complex (BCC) in the affected batch	Voluntary recall at the point of sales	Pharmaforte (Malaysia) Sdn. Bhd.,Malaysia	21 February 2024
8	Hyomide Tablet 10mg	MAL05101675AZ	Hyoscine butylbromide 10mg	2107056	Failure of related substances (tropic acid) assay test during stability study programme	Voluntary recall at the point of sales	Duopharma Maufacturing (Bangi) Sdn Bhd, Malaysia	13 March 2024
9	Listra Habbasauda 500mg Capsules	MAL16060013TC	Nigella sativa semen powder 500mg	TAAAZZAAALB 027-023	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall at the point of sales	Bina Mutiara Global Sdn Bhd, Malaysia	14 March 2024
10	viTasential Chlorophyllin Plus Liquid	MAL18026028N	Sodium Copper Chlorophyllin 90mg Spirulina (Spirulina platensis) 10mg Chlorella (Chlorella vulgaris) Concentrate 10mg	VCP0822001	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall at the point of sales	Sweet Heart Food Industries Sdn Bhd, Malaysia	14 March 2024
11	Hb" Well Capsule	MAL16060026TC	Herbs	23D1851	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall at the point of sales	Metro Signature Sdn Bhd, Malaysia	14 March 2024
12	Wai Yoen Gold Brand Wu Jin Wan (Big Pill)	MAL21026053T	Herbs	03238A	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall at the point of sales	Nutri-Home Pharmaceutical Industries Sdn Bhd, Malaysia	25 April 2024
13	Vivital Pharma Zivron Capsule	MAL16090042TC	Herbs	M005C23C	The batch tested by NPRA found to contain Bile- Tolerant Gram Negative Bacteria above allowable limit	Degree III recall at the point of sales	Ligno & Us Sdn Bhd, Malaysia	25 April 2024
14	Provin-C Capsule	MAL21086075T	Herbs	2306C0517	The batch tested by NPRA found to contain Total Yeast and Moulds Count above allowable limit	Degree III recall at the point of sales	Thiallan Bioherbs Sdn Bhd, Malaysia	25 April 2024
15	Ferrocyte Tablet 50mg	MAL19920395XZ	Ferric sodium citrate 50mg	1) 19A01S 2) 1ZA01S 3) 225A01S 4) 22XA01S 5) 231A01S 6) 235A01S 7) 237A01S 8) 242A01S	Out of specification for dissolution test at 12 months stored at 30°C/75% RH during annual stability study for batch 22XA01S	Voluntary recall at the point of sales	Eisai (Malaysia) Sdn Bhd, Malaysia	23 May 2024
16	Pantoprazole Sandoz 40mg Powder for Solution For Injection	MAL14125125AZ	Pantoprazole Sodium Sesquihydrate 40mg	NS0719	Formation of visible particles after reconstitution. The particles identification revealed to be a complex of Pantoprazole API adsorbed on siloxane/ silicone particles	Voluntary recall at the point of sales	Sandoz Products Malaysia Sdn Bhd, Malaysia	10 June 2024
17	Ilium Ketamil Injection	MAL15070027HA (for use in animals)	Ketamine Hydrochloride 100mg/mL	240130B	Reports of crystallization in a small number of vials for particular batch (240130B) as informed by the product manufacturer	Voluntary recall at the point of sales	Delfi Marketing Sdn. Bhd., Malaysia	14 June 2024
18	Shanghai Brand Ke Ou Du Tong San	MAL21096093TC	Herbs	SW32-003	The batch tested by NPRA found to contain Cadmium above the allowable limit	Degree II recall at the point of sales	Kheng Heng Medical (M) Sdn Bhd, Malaysia	14 June 2024
19	Dat's San Hong Yoke Wong (Syrup)	MAL20012968TC	Herbs	M0606T06	The batch tested by NPRA found to contain Total Yeast and Moulds Count above the allowable limit	Degree III recall at the point of sales	Tat Seo Health Factory Plt, Malaysia	14 June 2024
20	Tanamera Lemongrass and Ginger Herbal Tea	MAL16085043TC	Cymbopogon citratus (caulis) 1g Zingiber officinale (rhizome) 1g	23A02	The batch tested by NPRA found to contain Cadmium above the allowable limit	Degree II recall at the point of sales	Tanamera Tropical Spa Sdn Bhd, Malaysia	14 June 2024
21	HLP Raven Enema	MAL06011891XC	Glycerin 25% v/v Sodium Chloride 15% w/v	LR01A01	The batch tested by NPRA had failed physical appearance test	Voluntary recall at the point of sales	Sew Cheong Corporation Sdn Bhd, Malaysia	14 June 2024
22	Queen Jelly	MAL06011765T	Royal jelly 228mg	230701	The batch tested by NPRA found to contain Cadmium above the allowable limit	Degree II recall at the point of sales	Yi Wang Honey Garden (M) Sdn Bhd, Malaysia	18 July 2024
23	Megalive NutriFer Capsule	MAL18096093NC	Iron pyrophosphate 230mg (equivalent to 17.94mg Iron) Folic acid 0.9mg Vitamin C 50mg Vitamin B12 0.06mg Copper gluconate 14.28mg (equivalent to 2mg Copper)	DD0206	The batch tested by NPRA had failed assay test for Folic Acid	Degree III recall at the point of sales	Megalive BioSciences Sdn Bhd, Malaysia	18 July 2024
24	Hurix’s Gamat Plus Syrup	MAL21036096TC	Herbs	100mL Syrup Batch Number: • S050 231101 • S050 231201 • S050 231202 • S050 240101 • S050 240102 • S050 240103 • S050 240104	Recalls made following several complaints received by the company about the syrup appeared to be foamy after opening the cap which may indicates spoilage.	Voluntary recall at the point of sales	Jin Bin Corporation Sdn. Bhd., Malaysia	25 July 2024
25	Hurix’s Sirap Ubat Batuk Untuk Kanak-Kanak	MAL20033451TC	Herbs	60mL Syrup Batch Number: • S009 231101 • S009 231102 • S009 231201 • S009 231202 • S009 240101 • S009 240201	Recalls made following several complaints received by the company about the syrup appeared to be foamy after opening the cap which may indicates spoilage.	Voluntary recall at the point of sales	Jin Bin Corporation Sdn. Bhd., Malaysia	25 July 2024
26	Powerlife Turmeric Zingiber Ginkgo with Piper Nigrum Tablet	MAL21026076TC	Herbs	DF0147 DF0285	The colour of the tablets is different from the registered specification.	Voluntary recall at the point of sales	Powerlife (M) Sdn. Bhd., Malaysia	22 August 2024
27	Actimol Suspension 250mg/5mL	MAL20046151XZ	Paracetamol 250mg/5mL	5031695	The assay test for active pharmaceutical ingredient (paracetamol) conducted on the retention sample for batch 5031695 revealed out of specification results.	Voluntary recall at the point of sales	Idaman Pharma Manufacturing Sdn. Bhd., Malaysia	27 August 2024
28	Ban Kah Chai Gold Brand Cordyceps Luo Han Guo Cough Syrup Plus	MAL07101292TC	Herbs	BN2404/23 BN2405/23 BN2401/24 BN2402/24	This recall is being carried out following an out-of- specification result for the volume test conducted on the affected batch.	Voluntary recall at the point of sub-distributors (wholesaler)	Ban Kah Chai Pharmaceutical Sdn. Bhd., Malaysia	4 October 2024
29	Apo-Amitriptyline 10mg Tablet	MAL19984714ARZ	Amitriptylline Hydrochloride 10 mg	TW2842	The recall is being carried out following the decision regarding the content of N-nitroso-nortriptyline (NNORT) reported by Health Canada for batch TF8586, TF8587 and TF8589. The additional batches (TW2842) are recalled as a precautionary measure.	Voluntary recall at the point of sales	Pharmaforte (Malaysia) Sdn. Bhd., Malaysia	30 October 2024

Last update : 05/12/2024

Year 2023

No	Product Name	Registration Number	Active Ingredients	Batch Number	Reason for Recall	Degree and Level of Recall	Registration Holder	Date of Recall
1	Storvas C 20mg tablet	MAL11060016AZ	Atorvastatin Calcium 20mg/tablet	19121372 20040326 21010027	Out of specification of “Any Individual Impurity” in Related Substance Test of the product	Voluntary recall at the point of sales	Ranbaxy (Malaysia) Sdn Bhd	06 January 2023
2	Storvas C 40mg tablet	MAL11060017AZ	Atorvastatin Calcium 40mg/tablet	19121375 20030269 19121378 20081033 20040372	Out of specification of “Any Individual Impurity” in Related Substance Test of the product	Voluntary recall at the point of sales	Ranbaxy (Malaysia) Sdn Bhd	16 January 2023
3	Hermosa Maca 500mg Chewable Tablet	MAL20086112TC	Radix Lepidium meyenii 500mg	T0121T01	The batch tested by NPRA found to contain Cadmium above allowable limit	Degree II recall at the point of sales	Ecorigin Plt	17 January 2023
4	Xetec Tablet 10mg	MAL20040625AZ	Cetirizine Dihydrochloride 10mg	XE 20L 001	The batch tested by NPRA failed dissolution test and found to contain any secondary peak and Total impurities above specification limit	Degree II recall at the point of sales	SM Pharmaceuticals Sdn Bhd	17 January 2023
5	Gabata 300 (Gabapentin Capsules USP 300mg)	MAL19016037AZ	Gabapentin 300mg	21145468 20141660	Out of specification for “Any other individual impurities” was reported during stability study testing	Voluntary recall at the point of sales	Ascend Laboratories Sdn. Bhd.	08 February 2023
6	Bravecto 1400mg Chewable tablet for large dogs	MAL20026086HAR	Fluralaner 1400mg Chewable Tablet	22M5075A01	Label incompliance	Voluntary recall at the point of sales	Intervet (M) Sdn. Bhd.	09 February 2023
7	Cap Gunting Chai Teck Sang Shui Gan Teh 12gm	MAL20116092TC	Multiple active ingredients (Herbs)	22A007	The batch tested by NPRA found to contain Total Aerobic Microbial Count, Total Yeasts and Moulds Count and Bile-Tolerant Gram Negative Bacteria above allowable limit	Degree III recall at the point of sales	Chai Teck Sang Medical Hall Sdn Bhd	28 February 2023
8	WHP Modified Lian Hua Qing Wen Capsule	MAL21056079T	Multiple active ingredients (Herbs)	220315	The batch tested by NPRA found to contain cadmium and lead above the allowable limit	Degree II recall at the point of sales	White Heron Pharmaceutical Sdn. Bhd.	28 February 2023
9	Actimol Suspension 250mg/5mL	MAL20046151XZ	Paracetamol	5026851	Out of specification for assay during accelerated and real time stability study testing	Voluntary recall at the point of sales	Idaman Pharma Manufacturing Sdn. Bhd.	17 March 2023
10	Duro-Tuss Regular Cough Liquid 1mg/mL Kenyataan Media KPK	MAL13025049ACZ	Pholcodine 1mg/1mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Inova Pharmaceuticals (Singapore) Pte Ltd (Incorporated in Singapore) Malaysia Branch	20 March 2023
11	Duro-Tuss Forte Cough Liquid 3mg/mL Kenyataan Media KPK	MAL13025050ACZ	Pholcodine 3mg/ 1mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Inova Pharmaceuticals (Singapore) Pte Ltd (Incorporated in Singapore) Malaysia Branch	20 March 2023
12	Duro-Tuss Expectorant Cough Liquid Kenyataan Media KPK	MAL13025051ACZ	Pholcodine 1mg /1mL Bromhexine HCl 0.8mg/ 1mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Inova Pharmaceuticals (Singapore) Pte Ltd (Incorporated in Singapore) Malaysia Branch	20 March 2023
13	Difflam Anti-Inflammatory Antibacterial Lozenges With Cough Suppressant Kenyataan Media KPK	MAL14075076ACZ	Pholcodine 5.5mg Benzydamine hydrochloride 1.5mg Cetylpyridinium Chloride 1.33mg	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Inova Pharmaceuticals (Singapore) Pte Ltd (Incorporated in Singapore) Malaysia Branch	20 March 2023
14	Russedyl Compound Linctus Kenyataan Media KPK	MAL14055155AZ	Pholcodine 5mg/ 5mL Phenylephrine Hydrochloride 10mg/ 5mL Promethazine Hydrochloride 3.6mg/ 5mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Pharmaniaga Manufacturing Berhad	20 March 2023
15	Promedyl Plus Linctus Kenyataan Media KPK	MAL20033514AZ	Pholcodine 10mg/ 5mL Chlorpheniramine Maleate 4mg/ 5mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Duopharma Marketing Sdn. Bhd.	20 March 2023
16	Pholcodyl Syrup Kenyataan Media KPK	MAL05072033AZ	Pholcodine 5mg/ 5mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Sunward Pharmaceutical Sdn. Bhd.	20 March 2023
17	Pholcodyl Forte Syrup Kenyataan Media KPK	MAL05072034AZ	Pholcodine 15mg/ 5mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Sunward Pharmaceutical Sdn. Bhd.	20 March 2023
18	Rhynacol F Syrup Kenyataan Media KPK	MAL08010750AZ	Pholcodine 15mg/ 5mL Triprolidene Hydrochloride 2.5mg/ 5mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Sunward Pharmaceutical Sdn. Bhd.	20 March 2023
19	Ducodin Forte Linctus 15mg/5mL Kenyataan Media KPK	MAL07101250AZ	Pholcodine 15mg/ 5mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Hovid Berhad	20 March 2023
20	Ducodin Linctus 5mg/5mL Kenyataan Media KPK	MAL07101251AZ	Pholcodine 5mg/ 5mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Hovid Berhad	20 March 2023
21	Tussedyl Forte Syrup 15mg/5mL Kenyataan Media KPK	MAL06121115AZ	Pholcodine 15mg/ 5mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Pahang Pharmacy Sdn. Bhd.	20 March 2023
22	Axcel Iridin Linctus Kenyataan Media KPK	MAL09020970AZ	Pholcodine 10mg/ 5mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Kotra Pharma (M) Sdn. Bhd.	20 March 2023
23	Axcel Iridin Plus Linctus Kenyataan Media KPK	MAL09051551AZ	Pholcodine 5mg/ 5mL Triprolidene Hydrochloride 1.25mg/ 5mL	All batches	The risk of anaphylaxis due to exposure to pholcodine in patients who have been administered neuromuscular blocking agents (NMBA)	Degree II recall from all consumers (end users)	Kotra Pharma (M) Sdn. Bhd.	20 March 2023
24	Zyrtec-D Tablet	MAL06061671ARZ	Cetirizine dihydrochloride and Pseudoephedrine hydrochloride	321907	Packaging defect	Voluntary recall at the consumer level (end users)	GlaxoSmithKline Pharmaceutical Sdn. Bhd.	29 March 2023
25	Moxied CLV Injection 600mg	MAL20041268AZ	Amoxycillin sodium 500mg, Potassium clavulanate 100mg	APE204	Out of specification observed during routine viable environmental monitoring	Voluntary recall at the point of sales	SM Pharmaceuticals Sdn. Bhd.	05 May 2023
26	Moxied CLV Injection 1.2g	MAL20041269AZ	Amoxycillin sodium 1000mg, Potassium clavulanate 200mg	API101 API204	Out of specification observed during routine viable environmental monitoring	Voluntary recall at the point of sales	SM Pharmaceuticals Sdn. Bhd.	05 May 2023
27	Mesporin-1000 I.V. Vials	MAL20013996ACZ	Ceftriaxone	Z0027Z0054 Z0108Z0125 Z0108Z0133 Z0139Z0184	Detection of visible particles in the reconstituted powder	Voluntary recall at the point of sales	Mepharm (Malaysia) Sdn. Bhd.	17 May 2023
28	Eno Fruit Salt Lemon	MAL19962147XR	Sodium bicarbonate, Citric acid, Sodium carbonate	XT4E XT4G	The impacted batch may potentially be contaminated with foreign materials	Voluntary recall at the distributor level	GlaxoSmithKline Consumer Healthcare Sdn. Bhd.	14 June 2023
29	Ecort cream	MAL19913384AZ	Econazole nitrate 1% w/w and triamcinolone 0.1% w/w	23E1470	Label incompliance	Voluntary recall at the point of sales	Dynapharm (M) Sdn. Bhd.	23 June 2023
30	Holistica Coflix Liquid	MAL20116054TC	Multiple active ingredients (Herbs)	7228221221B	There is a risk of glass fragment present in the bottle of the product	Voluntary recall at the consumer level (end users)	Eldon Healthcare Sdn. Bhd.	27 June 2023
31	Sabril 500mg Tablet	MAL19961357AZ	Vigabatrin 500mg	2991A	Detection of traces of tiapride originated from API vigabatrin	Voluntary recall at the point of sales	Sanofi-Aventis (Malaysia) Sdn. Bhd.	18 July 2023
32	Apo-acyclovir 400mg	MAL19984322ARZ	Acyclovir 400mg	TH6095	Impurity N-nitrosodimethylamine (NDMA) was found to exceed the acceptable intake limit in batch TH6095	Voluntary recall at the point of sales	Pharmaforte (Malaysia) Sdn. Bhd.	18 August 2023
33	Apo-acyclovir 800mg	MAL19984323ARZ	Acyclovir 800mg	TK3920 TF4478	Following voluntary recall of Apo-acyclovir 400mg (batch TH6095), as a precautionary measure, the company extends the recall to include two additional batches, TK3920 and TF4478	Voluntary recall at the point of sales	Pharmaforte (Malaysia) Sdn. Bhd.	18 August 2023
34	Alesone Cream	MAL20040076AZ	Mometasone furoate 0.1% w/w	E2104043	The batch tested by NPRA failed assay test for Mometasone furoate	Degree II recall at the point of sales	Prime Pharmaceutical Sdn Bhd	28 February 2023
35	Li Zhong Tang Extract Powder “Sheng Chang”	MAL10012457T	Herbs	CP3411210	The batch tested by NPRA found to contain Bile-Tolerant Gram Negative Bacteria above allowable limit	Degree III recall at the point of sales	Lifecare Essential Sdn Bhd	28 February 2023
36	Lartil Injection 1mL (12.5 mg/mL)	MAL19970964AZ	Prochlorperazine Mesylate 12.5mg /1 ml	212603L	The batch tested by NPRA found to contain related substances that were out of specification limit	Degree II recall at the point of sales	Duopharma (M) Sdn Bhd	28 February 2023
37	Ke Ou Du Tong San (kim Loong Brand)	MAL20000959TC	Herbs	2202-22B20	The batch tested by NPRA found to contain cadmium above allowable limit	Degree II recall at the point of sales	Jin Loong Enterprise Sdn Bhd	28 February 2023
38	Ubat akar-akar the sejuk cap Tan Ngan Lo 6g/bag	MAL19950944T	Herbs	BBCT721	The batch tested by NPRA found to contain cadmium above allowable limit	Degree II recall at the point of sales	Wen Jiang Medical Industries Sdn Bhd	28 February 2023
39	Chuan Pei Plus Powder Shanghai Brand	MAL20076113TC	Herbs	22B7002	The batch tested by NPRA found to contain Bile-Tolerant Gram-Negative Bacteria above allowable limit	Degree III recall at the point of sales	Keng Heng Medical (M) Sdn Bhd	11 April 2023
40	Skin-Fix cream	MAL15070014TC	Channa striatus extract 4g	22SC02	The batch tested by NPRA found to contain Total Yeasts and Moulds Count above allowable limit	Degree III recall at the point of sales	Truelifesciences Holdings Sdn Bhd	11 April 2023
41	Throat Medicated Powder	MAL05023417T	Herbs	073220401	The batch tested by NPRA found to contain cadmium and lead above allowable limit	Degree II recall at the point of sales	Herbal Land Manufacturing Sdn Bhd	11 April 2023
42	Nutri-Home Chin Choo Watermelon Frost Plus 2.2gm	MAL20001664T	Herbs	09208A	The batch tested by NPRA found to contain cadmium and Total Aerobic Microbial Count above allowable limit	Degree II recall at the point of sales	Nutri-Home Pharmaceutical Industries Sdn Bhd	11 April 2023
43	Golf Tong Jin Wan	MAL05121297T	Herbs	22B8010	The batch tested by NPRA found to contain cadmium above allowable limit	Degree II recall at the point of sales	Shanghai Chatlin Pharmaceutical Company	14 July 2023
44	Musclesmooth Herbal Plaster	MAL10100092T	Herbs	MUPUURA001	The batch tested by NPRA found to contain cadmium above allowable limit	Degree II recall at the point of sales	Sun Ten Pharmaceutical Mfg (M) Sdn Bhd	14 July 2023
45	Yung Kien Ganoderma 2 capsules	MAL10120091T	Extract of Ganoderma tsugae fruit body 450mg	A2BH291	The batch tested by NPRA found to contain cadmium above allowable limit	Degree II recall at the point of sales	Shuang Hor Enterprise (M) Sdn Bhd	14 July 2023
46	Dynalexin dry syrup 125mg/5ml	MAL07031083AZ	Cephalexin monohydrate	22S2374	Packaging defect	Voluntary recall at the point of sales	Dynapharm (M) Sdn. Bhd	08 August 2023
47	Guo Ma Ba Bao San (Powder)	MAL19988658T	Herbs	BBS2302	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall at the point of sales	Shin Li Trading	24 August 2023
48	Phytosophy Phyto Chlorophyll Plus Liquid	MAL16070029T	Chlorophyll powder 120mg Chlorella pyrenoidosa 40mg Potassium sorbate 0.03%	PTC 1400	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall at the point of sales	PHHP Group Sdn Bhd	24 August 2023
49	Shafli Teh Herba Gaharu	MAL13115169T	Folium Aquilaria malaccensis 1.5g	GT1001-0323	The batch tested by NPRA found to contain Cadmium above allowable limit	Degree II recall at the point of sales	Shafli Lagenda Sdn Bhd	22 September 2023
50	Alfa-D 1.00mcg Capsule	MAL09061594X	Alfacalcidol 1.00 mcg	22E72 & 22E73	The assay for Alfacalcidol conducted on batch 22E72 & 22E73 was found to be out of specifications during real time stability study at 12 months point	Voluntary recall at the point of sales	Pahang Pharmacy Sdn Bhd	27 September 2023
51	Di Ann Du Tong San	MAL20032112T	Herbs	All batches	The batch tested by NPRA found to contain Total Aerobic Microbial Count (TAMC) above allowable limit	Degree III recall at the point of sales	Di Ann Trading	01 November 2023
52	Honesty Healthcare American Ginseng 300 mg capsule	MAL05051191TC	Radix Panax quinquefolium L. 300mg	220108	The batch tested by NPRA found to contain cadmium above allowable limit	Degree II recall at the point of sales	Conforer Medi-Care Enterprise	01 November 2023
53	Wykon Xiao Er Bao Yin San	MAL21116118TC	Herbs	WBY22L01E	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall at the point of sales	Wykon Medical Sdn Bhd	01 November 2023
54	IME-9 Tablets	MAL21016096T	Herbs	157	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall at the point of sales	Ayush 82 Resources	01 November 2023
55	Omiflu Capsule 75mg	MAL07090926AZ	Oseltamivir phosphate	200879L	Failure of organic impurities and assay test during stability study programme	Voluntary recall at the point of sales	Duopharma (M) Sdn Bhd	17 November 2023
56	Ekoplast Medicated Plaster	MAL21096001XC	Ginger oil 4% w/w Methyl salicylate 4% w/w Menthol 2.5% w/w Camphor 1.8% w/w	V2212008	The batch tested by NPRA failed assay test for Methyl Salicylate	Degree III recall at the point of sales	Ee Koh Enterprise Sdn Bhd	20 December 2023
57	Shou Hsing Brand BuYao Pill (small)	MAL16120044TC	Herbs	9171220722	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall at the point of sales	Chua Tongsan Sdn Bhd	20 December 2023
58	Greenherbs Cough with Honey for kids liquid	MAL16080050T	Herbs	9165221214	The batch tested by NPRA found to contain Total Aerobic Microbial Count and Total Yeasts and Moulds Count above allowable limit	Degree III recall at the point of sales	Biofact Life Sdn Bhd	20 December 2023
59	Makjun Seri Perisai	MAL20012966T	Herbs	SP220501	The batch tested by NPRA found to contain Total Aerobic Microbial Count above allowable limit	Degree III recall at the point of sales	Syarikat Mutiara	20 December 2023

Last update : 20/08/2024

Product Recall

Definition

More Links

More Links

DISCLAIMER

Site Last Modified

Online Services

Search

Main Menu English

Choose Your Language