Drug Enforcement D-0257-2024

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

Status

Ongoing

Classification

Class III

Report Date

January 31, 2024

Termination Date

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Product Information

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
Product quantity
6,344 cartons
Reason for recall
Superpotent drug: Assay results were slightly above specification at the time zero point.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Amerisource Health Services LLC
Address
2550 John Glenn Ave Ste A, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0257-2024
Event ID
93778
Recall initiation date
December 26, 2023
Center classification date
January 19, 2024
Code info
Lot # 1014208, Exp Mar/31/2025
More code info
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