Class III

Drug Recall: 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

Amerisource Health Services LLC · December 26, 2023

Reason for Recall

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

Product Description

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

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

6,344 cartons

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0257-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.