Class II · Moderate risk Ongoing
HydrALAZINE Hydrochloride
Reason Failed Impurities/Degradation Specifications
hydrALAZINE HCl Tablet
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
What was recalled
hydrALAZINE HCl Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 50111032801
- Recalling firm
- Aidapak Services, LLC
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-591-2014
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.
Other Hydralazine recalls
See all
Class II · Moderate risk Ongoing
HydrALAZINE Hydrochloride
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Hydralazine HCl Tablets
Reason Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Class II · Moderate risk Terminated
HydrALAZINE Hydrochloride Tablets
Reason an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Class III · Low risk Ongoing
HydrALAZINE Hydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.
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