Amneal primidone tablets recalled for potential cross-contamination
Amneal Pharmaceuticals is recalling Primidone 50 mg tablets (NDC 53746-544-01, lot AM251676) due to potential cross-contamination with Acemetacin during manufacturing at the API supplier. The contamination could affect the safety or effectiveness of the medication.
From the FDA notice · Read the official notice ↗ · All Amneal Pharmaceuticals recalls
What to do
- Contact your pharmacist or doctor if you have this medication — do not stop taking it without medical guidance.
- Check the lot number on your bottle against lot AM251676 and expiration date 11/31/2028.
- Return recalled bottles to your pharmacy or contact Amneal Pharmaceuticals for instructions.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 27,936 100-count bottles
- Illnesses reported
- None reported
- Manufactured in
- 400 Crossing Blvd Fl 3, N/A, Bridgewater, NJ, United States
- Classification
- Class III
- Recall number
- D-0585-2026
In the FDA's words
- Description
- Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01 Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. Lot AM251676, EXP 11/31/2028 Distribution: Nationwide within the USA. Affected quantity: 27,936 100-count bottles
- Hazard
- Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
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