FDA Recall D-0257-2024

Amerisource Health Services LLC · Columbus, OH

Class III Ongoing 870 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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

Lot / code: Lot # 1014208, Exp Mar/31/2025

Quantity: 6,344 cartons

Reason for recall

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

Recall record

Recall number: D-0257-2024
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2023-12-26
Classified by FDA Center: 2024-01-19
FDA published: 2024-01-31
Recalling firm: Amerisource Health Services LLC
Firm location: Columbus, OH

Drug identification

Brand name(s): BENZONATATE
Generic name(s): BENZONATATE
Manufacturer(s): American Health Packaging
NDC(s): 68084-214
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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