Recalls / Class II
Class IID-0653-2022
Product
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
- Affected lot / code info
- Lot #: T03755, T03756, Exp. Date 03/2023
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Recalling firm
- Firm
- The Harvard Drug Group
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 17187 N Laurel Park Dr Ste 300, N/A, Livonia, Michigan 48152-2600
Distribution
- Quantity
- 5,953 cartons
- Distribution pattern
- Nationwide within USA
Timeline
- Recall initiated
- 2022-02-24
- FDA classified
- 2022-03-14
- Posted by FDA
- 2022-03-23
- Terminated
- 2023-07-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0653-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.