The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying healthcare providers that Pfizer has warned on the presence of boxes of probable authentic Prevenar 13 displaying tampered expiry date.
According to the Marketing Authorization Holder (MAH) Pfizer, a patient notification received from Nigeria informed the company of a suspicious pack of Prevenar 13 with shared pictures showing the expiry date of the product pack to be tampered.
On investigation, the information was shared with the Pfizer anti-counterfeit laboratory in Groton USA for a visual analysis. The visual analysis conclusion from the laboratory states.
“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 for the Nigerian Market.
The correct manufacture date for lot CL3337 is 03/20219.
The correct expiry date for lot CL3337 is 02/2022.
Expanded view of expiry date, showing tampering to month and year.
Month- changed from 02 to 12.
Year- changed from 2022 to 2024.’’
The complete visual assessment conclusion, including the pictures, is copied below.
Although a chemical analysis is yet to be conducted on the product by Pfizer since it is yet to receive the sample from the reporter, the elements above indicate that the product featured in the picture above has been tampered with and its expiry date has been extended by more than two years.
Please note that the Original brand of Prevenar 13 is registered with NAFDAC with the number A6-0117.
NAFDAC implores healthcare providers to always exercise caution and vigilance within the supply chain to avoid the purchase, administration, or use of falsified or substandard medicinal products. All medical products must be obtained from authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
Patients in possession of the above-mentioned product are advised to discontinue use and submit stock to the nearest NAFDAC office. In the event of adverse reaction suffered from the use of the product, patients are advised to seek immediate medical attention from a qualified healthcare professional.
Healthcare professionals and consumers are advised to report any suspicion of adverse events, substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: sf.alert@nafdac.gov.ng
Healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of 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
NAFDAC……….Customer-focused, Agency-minded!!!
Signed Management
