Recall: D-0257-2024

Class III - Minor Violations

Class IIIClassification

2023-12-26Initiated

OngoingStatus

Amerisource Health Services LLFirm

Product

Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11

Reason

Superpotent drug: Assay results were slightly above specification at the time zero point.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.