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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) SB 23 January 2024
 2

 Tenormin Tablet 50mg

MAL19870055ACZ

Atenolol 50mg

6004731

label incompliance

Voluntary recall at the point of sales

DKSH Malaysia Sdn Bhd 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 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, 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, 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. 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 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 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 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 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 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 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 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 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. 14 June 2024


 

 Last update : 20/8/2024

Year 2023

 

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400

 

 

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Site Last Modified

  • Last Modified: Friday 08 November 2024, 07:07:02.

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