Drug 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
D-0257-2024
Product summary
- Event
- Event 93778
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 6,344 cartons
- Official record key
drug-enforcement:D-0257-2024
Official wording
Reason: Superpotent drug: Assay results were slightly above specification at the time zero point.
Code information: Lot # 1014208, Exp Mar/31/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Superpotent