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Recall Observatory FDA recall evidence

Drug product

HydrALAZINE Hydrochloride, 25 mg, 100 Unit Dose Tablets (10x10), USP, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India, Distributed by McKesson by: McKesson Corporation dba SKY Packaging, TN 38141. NDC 63739-327-10

D-0219-2025

January 24, 2025

Class II

Product summary

Firm
SKY PACKAGING
Event
Event 96159
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0219-2025

Official wording

Reason: Failed Impurities/Degradation Specifications

Code information: Lot #: 0000127312, Exp. Date 31-Mar-2025; 0000127576, 0000127577, Exp. Date 31-Jul-2025; 0000128204, Exp. Date 31-Dec-2025; 0000128358, Exp. Date 31-Jan-2026

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications