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Recall Observatory FDA recall evidence

Drug product

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

D-0320-2024

February 01, 2024

Class III

Product summary

Firm
Amerisource Health Services LLC
Event
Event 93936
Status
Ongoing
Classification
Class III
Quantity
2,850 cartons
Official record key
drug-enforcement:D-0320-2024

Official wording

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

Code information: Lot #: 1012275, Exp 02/28/2025

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of Specification