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Public Alert No. 032/2025 – Alert on the Discontinuation of the Production of Penicillin-Based Moiety by Miraflash

The National Agency for Food and Drug Administration and Control (NAFDAC) is informing the public about Miraflash Nigeria Limited’s decision to cease production of its penicillin-based products.

This decision, taken by Miraflash Nigeria Limited, has nothing to do with the quality or safety of the penicillin-based products produced within their facility, but rather to avoid the high risk of cross-contamination and meet NAFDAC’s regulatory requirements that strictly prohibit the co-production of penicillin-based products and cephalosporins in the same manufacturing facility.

Penicillin and cephalosporin are powders and easily aerosolized and can travel through shared HVAC systems, thereby posing the risk of cross-contamination of equipment and packaging lines. Penicillin residues are extremely difficult to eliminate, even with thorough cleaning.

Miraflash Nig Ltd has decided to concentrate on the production of cephalosporins only in the current factory until it can secure a separate plant for the manufacture of penicillin-based products to avoid cross-contamination.

Note that all Miraflash penicillin-based products manufactured in August 2025 currently in circulation are good for use as they were produced before this decision was taken. Any product produced after the specified date will be deemed counterfeit. Any time Miraflash resumes the production of the penicillins, they must inform the public following due process.

Below is a list of all the affected penicillin-based products being discontinued after the last production in August 2025, 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 the last production date of the above-mentioned products.

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: 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 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!!!

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