HydrALAZINE Hydrochloride, 100 Tablets (10x10), USP, 50mg, Rx only, Manufactured by Strides Pharma Science Ltd, Bengaluru, India…
Reason Failed Impurities/Degradation Specifications
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup; hydrALAZINE HCl Tablet, 50 mg may be potentially mislabeled as CapsuleTOPRIL, Tablet, 12.5 mg, NDC 00143117101, Pedigree: AD52778_16, EXP: 5/20/2014.
hydrALAZINE HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111032801
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Reason an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product…
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the…
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