PositiveNaija Public Alert 37: NAFDAC Notifies on the Discontinuation of the Production of Penicillin-Based Moiety by Miraflash

PositiveNaija Public Alert 37: The National Agency for Food and Drug Administration and Control (NAFDAC) is notifying the public of the decision to discontinue the production of penicillin-based products by Miraflash Nigeria Limited.

This decision is taken as a corrective measure and closure of a critical observation made during a GMP inspection conducted in the company by a team of NAFDAC officers in June 2024.

Below is a list of all the affected penicillin-based products being discontinued, with their NAFDAC registration numbers:

S/N Name of Product Generic Name NAFDAC No.
1 Miramox 125mg Powder for Oral Suspension Amoxicillin 04-6869
2 Miramox 250mg Powder for Oral Suspension Amoxicillin A11-0999
3 Miramox 500mg Capsules Amoxicillin B4-5536
4 Miraclox 250mg Powder for Oral Suspension Ampicillin/Cloxacillin 04-7004
5 Miraclox 500mg Capsules Ampicillin/Cloxacillin A11-0038
6 Mirapicin 125mg Powder for Oral Suspension Ampicillin 04-6868
7 Mirapicin 250mg Capsules Ampicillin B4-5538
8 Miraclox 90mg Powder for Oral drops Ampicillin/Cloxacillin A4-0044

NAFDAC hereby advises all relevant stakeholders to note this discontinuation and take necessary steps to ensure the proper transition to alternative sources of penicillin-based medicines where required.

  • Discontinue ordering or restocking penicillin-based products manufactured by Miraflash Nigeria Limited.
  • Verify product availability from other authorized and licensed manufacturers.
  • Report any suspected substandard or falsified penicillin-based products claiming to be from Miraflash Nigeria Limited to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: alert@nafdac.gov.ng

Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices 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

 

 

PositiveNaija Public Alert

The PositiveNaija Public Alert 37 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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