Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Dist...
FDA Recall #D-0257-2024 — Class III — December 26, 2023
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
Reason for Recall
Superpotent drug: Assay results were slightly above specification at the time zero point.
Recalling Firm
Amerisource Health Services LLC — Columbus, OH
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
6,344 cartons
Distribution
Nationwide in the USA
Code Information
Lot # 1014208, Exp Mar/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated