Recalls / Class II
Class IID-0324-2024
Product
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61
- Affected lot / code info
- Lot #: T04680, Exp. Date 6/2024
Why it was recalled
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.
Recalling firm
- Firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 341 Mason Rd, N/A, La Vergne, Tennessee 37086-3606
Distribution
- Quantity
- 8,198 units
- Distribution pattern
- The product was distributed nationwide within the United States.
Timeline
- Recall initiated
- 2024-02-09
- FDA classified
- 2024-02-13
- Posted by FDA
- 2024-02-21
- Terminated
- 2025-12-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0324-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.