PositiveNaija Public Alert 6: NAFDAC Confirms Cases Of Two Counterfeit Batches of Avastin 400mg/16ml, Manufactured By Roche Diagnostics Public Gmbh, Mannheim, Germany

PositiveNaija Public Alert 6: The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public of two confirmed cases of two batches of counterfeit AVASTIN 400mg/16ml with batch number H0223B08 and H4239A70 in Nigeria.

The Marketing Authorization Holder (MAH) Roche notified the Agency that a pharmacist reported the purchase of the counterfeited Avastin Vials 400 mg/16 ml, batch H0223B08 by a patient from a pharmacy in Kano. This batch has earlier been published in a previous public alert from NAFDAC. Similarly, another counterfeited Avastin Vials 400 mg/16 ml, batch H4239A70 was reported by a Pharmacist in the Federal Medical Center, in Abuja.

However, investigation has confirmed that the genuine batch number H0223B08 is associated with Avastin 400mg/16ml in Vietnamese make-up, the genuine product was distributed to Vietnam in July 2020, and the batch H0223B08 already expired in July 2022.

Also, the investigation revealed that no batch tracing was possible for Avastin 400mg/16ml with batch no H4239A70 as this is not a genuine Roche product and the batch number doesn’t exist in their database.

Avastin 400mg Injection is an anticancer medication. It is used in the treatment of cancer of the colon and rectum, non-small cell lung cancer, kidney cancer, brain tumor, ovarian and cervical cancer. It helps to prevent the growth of new blood vessels that feed tumors and stops tumors from growing.

Possible Risks

Counterfeit medicines may be harmful to health because while being passed off as authentic, it may contain the wrong ingredients, contain too much, too little or no active ingredient at all or contain other harmful ingredients and can result to poisoning,treatment failure and compromised drug effectiveness.

Product Details

The details of the affected product are as follows

Note: The correct manufacturing site for genuine Avastine vial 400mg/16ml is Roche Diagnostics GmbH Sandhofer Strasse 11668305, Mannheim, Germany.

NAFDAC implores importers, distributors, retailers and consumers to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale and use of the affected lots of the product. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.

Anyone in possession of any of the counterfeit lots is advised to immediately discontinue sale or use and submit stock to the nearest NAFDAC office. If you have used any of the product, or someone you know, have used it, or suffered any adverse reaction/event after use, you are advised to seek immediate medical advice from a qualified healthcare professional.

Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng

Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of the medicinal product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng or via the Med-safety application available for download on android and IOS stores or via e-mail on pharmacovigilance@nafdac.gov.ng

Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).

PositiveNaija Public Alert

The PositiveNaija Public Alert 6 initiative is aimed at keeping Nigerians well-informed particularly in regards to their safety and development. For future developments on this news, kindly follow up through the official communication channels of the reporting/regulatory authority.

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