Product Recall

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A drug recall is the most effective way to protect the public from a defective or potentially harmful product. A recall is a voluntary action taken by a company at any time to remove a defective drug product from the market.

 

A drug recall is the most effective way to protect the public from a defective or potentially harmful product. A recall is a voluntary action taken by a company to remove a defective drug product from the market. Drug recalls may be conducted on a company’s own initiative or by the Ministry of Health Malaysia's request. NPRA's role in a recall is to oversee a company’s strategy, assess the adequacy of the recall and classify the recall.

 

Recall Classification

Class I:      A dangerous or defective product that could cause serious health problems or death.

Class II:     A product that might cause a temporary health problem, or pose slight threat of a serious nature.

Class III:   A product that is unlikely to cause any adverse health reaction, but that violates NPRA labelling or manufacturing laws.

 

Alerting the Public

Not all recalls are announced on NPRA's website or in the press release statements. Public notification is generally issued when a product that has been widely distributed or poses a serious health hazard is recalled. However, if a company does not issue public notification of a recall, NPRA may do so if the agency determines it is necessary to protect patients. Patients also may learn that their medicine has been recalled through notification from the manufacturer, their health care professional or pharmacist.

 

If you have a medicine that has been recalled, talk to your health care professional about the best course of action for your health, including the possibility of returning the product to the store in which you purchased it.

 

Stores generally have a return and refund policy when a company has announced a recall of its products. Generally, Class I recall notifications provide instructions with actions for patients. NPRA recommends that patients follow the instructions provided by the recalling company.

 

Press Release

All recalls are posted in the press release section and product recall section in the NPRA's website. Recalls that are classified will have a classification of Class I, Class II or Class III based on the level of hazard. Ongoing recalls that have not been classified are also published in the safety alerts as “not yet classified” in the classification field. After the recall classification has been determined, the recall is updated in the safety alerts with its appropriate classification.

 

Determining the Effectiveness of the Recall

NPRA evaluates the effectiveness of a recall by evaluating a company’s efforts to properly notify customers and remove the defective product from the market. If a recall is determined to be ineffective NPRA will request the company take additional actions.

 

The list of  voluntary recalls in which public notification has been issued and details on the product recalls can be obtained in press release section. 

 

 

 

 

 

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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.

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  • Last Modified: Friday 06 December 2019, 11:24:27.
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