Recalling firm
Amerisource Health Services LLC
Product type
Drug
Status
Ongoing
Report date
2024-01-31
Distribution
Nationwide in the USA
Firm state
OH
Product quantity
6,344 cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Superpotent drug: Assay results were slightly above specification at the time zero point.
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
Code / lot info
Lot # 1014208, Exp Mar/31/2025
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.