D-0324-2024 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- February 21, 2024
- Initiation Date
- February 9, 2024
- Termination Date
- December 22, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,198 units
Product Description
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
Reason for Recall
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.
Distribution Pattern
The product was distributed nationwide within the United States.
Code Information
Lot #: T04680, Exp. Date 6/2024