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 I – Products with major health risks that might cause serious injuries or death. Should be under an embargo within 24 hours.

Degree II – Products with minor health risks or are substandard. Should be under an embargo within 72 hours.

Degree III – Products with other reasons for recall. Should be under an embargo within 30 days or as specified.

 

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, Specialists 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 2023

 

No   Date of Recall  Product Name  Registration Number  Active Ingredients  Batch Number  Reason for Recall  Degree and Level of Recall  Registration Holder  Press Release/ 
Safety Information
 1  6   January   2023

 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

 
 2  16   January   2023

 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
 
 3  17   January   2023

 

 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  
 4  17   January   2023

 

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  
 5  8   February   2023

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.  
 6  9   February   2023

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.

 
 
 7  28   February   2023


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
 
 8  28   February   2023

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.  
 9  17   March   2023

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.   
 10  20   March   2023

Duro-Tuss Regular Cough Liquid 1mg/mL

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

 

Pholcodine
 11  20   March   2023

Duro-Tuss Forte Cough Liquid 3mg/mL

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

 Pholcodine
 12  20   March   2023

Duro-Tuss Expectorant Cough Liquid

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

 Pholcodine
 13  20   March   2023

Difflam Anti-Inflammatory Antibacterial Lozenges With Cough Suppressant

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

 Pholcodine
 14  20   March   2023

Russedyl Compound Linctus

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 Pholcodine 
 15  20   March   2023

Promedyl Plus Linctus

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.  Pholcodine
 16  20   March   2023

Pholcodyl  Syrup

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.

 

Pholcodine 
 17   20   March   2023

Pholcodyl  Forte Syrup

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.

Pholcodine 
 18  20   March   2023

Rhynacol F Syrup

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.

 Pholcodine
 19  20   March   2023

Ducodin Forte Linctus 15mg/5mL

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

 

Pholcodine  
 20  20   March   2023

Ducodin Linctus 5mg/5mL

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  Pholcodine
 21  20   March   2023

Tussedyl Forte Syrup 15mg/5mL

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. Pholcodine 
 22  20   March   2023

Axcel Iridin Linctus

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.

 

 Pholcodine
 23  20   March   2023

Axcel Iridin Plus Linctus

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.  Pholcodine
 24  29   March   2023

Zyrtec-D Tablet

MAL06061671ARZ

Cetirizine dihydrochloride and Pseudoephedrine hydrochloride

321907

Packaging defect

 Voluntary recall at the consumer level (end users)

GlaxoSmithKline Pharmaceutical Sdn. Bhd.  
 25  5 May   2023

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.  
 26  5 May   2023

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.  
 27  17 May   2023

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.  
 28  14 June   2023

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.  
 29  23 June   2023

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.  
 30  27 June   2023

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.  
 31  18 July   2023

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.  
32    18 August 2023 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.

 
33  18 August 2023

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.  


 

 Last update : 11/10/2023

 

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