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Recall Observatory FDA recall evidence

Drug product

HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01; Individual Dose NDC: 68084-447-11

D-0039-2024

September 01, 2023

Class III

Product summary

Firm
Amerisource Health Services LLC
Event
Event 93089
Status
Terminated
Classification
Class III
Quantity
3,344 cartons
Official record key
drug-enforcement:D-0039-2024

Official wording

Reason: Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.

Code information: Lot#: 1007002, Exp 12/31/2023

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of Specification