FDA recalls Carbamazepine Extended-Release Tablets, 400 mg, distributed nationwide by American Health Packaging. The recall cites failed dissolution specifications and class II classification. Consumers should stop using and contact healthcare providers for guidance.
Failed Dissolution Specifications.
Consumers and healthcare providers should stop using this product immediately. Contact Amerisource Health Services LLC or your healthcare provider for guidance. Notification method: Letter
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Carbamazepine extended-release tablets are used to treat seizures and nerve pain. This recall involves 360 cartons distributed nationwide.
Failure to dissolve as specified can alter drug release and absorption, potentially impacting effectiveness and safety.
This recall is not part of a broader industry pattern.
The recall may affect adherence to prescribed therapy and require medical guidance for safe continuation.
On the carton and patient information leaflets; FDA enforcement page for D-0675-2025
Refund or replacement timelines will be provided in recall communications by Amerisource Health Services LLC and pharmacies
Keep the recall notice, receipts, and any correspondence with healthcare providers or pharmacies
Carbamazepine Extended-Release Tablets, USP 400 mg. 30 tablets per carton (3x10 unit dose cards). Rx Only. Distributor: American Health Packaging, Columbus, OH 43217. Carton NDC 60687-594-21; Individual Dose NDC 60687-594-11. Quantity: 360 cartons. Lot #: 1024078. Exp. Date: 08/31/2026. Sold nationwide in the USA. Generic name CARBAMAZEPINE; Brand CARBAMAZEPINE.
No injuries or incidents have been reported in the provided data.
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