Class II · Moderate risk Ongoing
HydrALAZINE Hydrochloride
Reason Failed Impurities/Degradation Specifications
hydrALAZINE HCl Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
What was recalled
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
- Recalling firm
- The Harvard Drug Group
- NDC code
- 0904-6440-61
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0653-2022
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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