PlainRecalls
FDA Drug Low Class III Ongoing

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

Reported: January 31, 2024 Initiated: December 26, 2023 #D-0257-2024

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.

Details

Units Affected
6,344 cartons
Distribution
Nationwide in the USA
Location
Columbus, OH

Frequently Asked Questions

What product was recalled?
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. Recalled by Amerisource Health Services LLC. Units affected: 6,344 cartons.
Why was this product recalled?
Superpotent drug: Assay results were slightly above specification at the time zero point.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 31, 2024. Severity: Low. Recall number: D-0257-2024.