FDA recall D-0257-2024

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

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2023-12-26

Report date

2024-01-31

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0257-2024