FDAClass IIIJanuary 31, 2024

Benzonatate Capsules recall: Superpotent

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

Why was Benzonatate Capsules recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 1014208, Exp Mar/31/2025

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
Recalling firm
Amerisource Health Services LLC
Quantity
6,344 cartons
Distribution
Nationwide in the USA
Recall date
January 31, 2024
Classification
Class III
Status
Ongoing
Agency
FDA (drug)
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