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.
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