D-0257-2024 Class III Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- January 31, 2024
- Initiation Date
- December 26, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,344 cartons
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot # 1014208, Exp Mar/31/2025