Drug Enforcement D-0320-2024

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.

Status

Ongoing

Classification

Class III

Report Date

February 14, 2024

Termination Date

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Product Information

Product description
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11
Product quantity
2,850 cartons
Reason for recall
Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time 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

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

Codes & Dates

Recall number
D-0320-2024
Event ID
93936
Recall initiation date
February 1, 2024
Center classification date
February 8, 2024
Code info
Lot #: 1012275, Exp 02/28/2025
More code info
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