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
NAFDAC………. Customer-focused, Agency-minded!!!
