The National Agency for Food and Drugs Administration and Control (NAFDAC) has issued a warning to healthcare providers after Pfizer flagged the presence of boxes of Prevenar 13 with potentially tampered expiry dates.
Pfizer, the Marketing Authorization Holder (MAH) for Prevenar 13, received a patient notification from Nigeria, providing images of a suspicious pack of Prevenar 13 with an altered expiry date.
Following this report, Pfizer conducted a visual analysis at its anti-counterfeit laboratory in Groton, USA.
The visual analysis
- Probable authentic packaging for distribution in the Nigerian market, displaying a tampered expiry date.
- Lot CL3337 is confirmed as a valid lot for Prevenar 13 in the Nigerian market.
- The correct manufacturer date for Lot CL3337 is 03/20219.
- The correct expiry date for lot CL3337 is 02/2022.
- An expanded view of the expiry date shows tampering to month and year.
- The month changed from 02 to 12.
- The year changed from 2022 to 2024.
While a chemical analysis is pending until Pfizer receives the sample from the reporter, visual examination strongly suggests that the product depicted in the images has been tampered with, extending its expiry date by over two years.
It is essential to note that the original brand of Prevenar 13 is registered with NAFDAC under the number A6-0117.
NAFDAC is urging healthcare providers to exercise caution and vigilance in the supply chain, avoiding the purchase, administration, or use of potentially falsified or substandard medicinal products.
Authentic medical products should only be sourced from authorized and licensed suppliers, and their authenticity and physical condition carefully verified.
Patients who possess the mentioned product are advised to discontinue its use and submit the stock to the nearest NAFDAC office. In case of adverse reactions resulting from the use of the product, patients are advised to seek immediate medical attention from qualified healthcare professionals.
Healthcare professionals and consumers are encouraged to report any suspicion of adverse events, or substandard, or falsified medicines to the nearest NAFDAC office.
Additionally, healthcare professionals and patients can report adverse events or side effects related to the use of medicinal products to the nearest NAFDAC office.
E-reporting platforms are available on the NAFDAC website or through the Med-Safety application, downloadable on Android and IOS stores.