The National Agency for Food and Drugs Administration and Control (NAFDAC) is notifying the public about the mop up of batches of confirmed substandard Annmox (Batch 360M) and Jawamox (Batch 4231M & 4290M) Suspensions.
The products failed laboratory analysis due to low Active Pharmaceutical Ingredient (API) content.
The company has been directed to recall the failed batches from circulation.
Risk
The risk of low Active Pharmaceutical Ingredient (API) in medicines includes ineffective treatment, development of antimicrobial resistance, and serious safety concerns, such as increased risk of complications and misleading clinical assessment.
Also, the marketing of substandard medicines poses a great risk to public health.
Product Details
The details of the affected products and batches are as follows:
Product Name | Batch No | Mfg. Date | Exp. Date | NRN NO | Manufacturer | Distributors |
Annmox (Amoxicillin Suspensions 125mg/5ml)
| 360M
| 07/2026
| 07/2027
| A11-0329 | Jawa International Limited, Plot 6, Abimbola Way, Isolo Industrial Estate, Lagos.
| Annie Pharma Limited, A division of Jawa International Limited, Jawa House, Plot 6, Abimbola Way, Isolo Industrial Estate, Lagos. |
Jawamox (Amoxicillin Suspensions 125mg/5ml) | 4290M | 08/2024
| 07/2027
| 04-1139 | Jawa International Limited, Plot 6, Abimbola Way, Isolo Industrial Estate, Lagos.
| Jawa International Limited, Jawa House, Plot 6, Abimbola Way, Isolo Industrial Estate, Lagos.
|
Jawamox (Amoxicillin Suspensions 125mg/5ml) | 4231M
| 07/2024
| 06/2027 | 04-1139
| Same as above
| Same as above
|
All NAFDAC zonal directors and state coordinators have been directed to carry out surveillance and mop up the substandard/falsified products within their zones and states.
NAFDAC implores distributors, suppliers, wholesalers, healthcare providers, and patients to exercise caution and vigilance within the supply chain to avoid distribution, sales, administration, and use of the products. All medical products must be obtained from genuinely authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
If you have any of the products mentioned above, please stop selling or using them immediately and submit your stock to the nearest NAFDAC office. If you or someone you know has used any of these products and experienced adverse reactions or events, we strongly recommend seeking immediate medical advice from a qualified healthcare professional.
Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines 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 the 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
Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
NAFDAC………. Customer-focused, Agency-minded!!!
