FDA DrugClass IIINotable

FDA Recall: Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceutic

Date: 2026-06-17
Brand: Amneal Pharmaceuticals, LLC
Category: Drug
FDA Class: Class III

Description

Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

Hazard

Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

Remedy

27,936 100-count bottles

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