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) 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