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.
No | Date of Recall | Product Name | Registration Number | Active Ingredients | Batch Number | Reason for Recall | Degree and Level of Recall | Registration Holder |
1 |
6 January 2023 |
Storvas C 20mg tablet |
MAL11060016AZ |
Atorvastatin |
19121372 |
Out of specification of “Any Individual Impurity” in Related Substance Test of the product |
Voluntary recall at the point of sales |
Ranbaxy |
2 |
16 January 2023 |
Storvas C 40mg tablet |
MAL11060017AZ |
Atorvastatin |
19121375 |
Out of specification of “Any Individual Impurity” in Related Substance Test of the product |
Voluntary recall at the point of sales |
Ranbaxy |
3 |
17 January 2023 |
Hermosa Maca 500mg
|
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 |
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 |
|
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 |
|
Chai Teck Sang |
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
|
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 |
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 |
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 |
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 |
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. |
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.
|
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. |
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. |
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
|
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 |
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. |
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.
|
23 |
20 March 2023 |
Axcel Iridin Plus Linctus |
MAL09051551AZ |
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) |
Kotra Pharma (M) Sdn. Bhd. |
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 |
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 |
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 |
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