Status
Completed
Drug Enforcement D-0324-2024
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.
Classification
Class II
Report Date
February 21, 2024
Termination Date
—
Product Information
- 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
- Product quantity
- 8,198 units
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- The product was distributed nationwide within the United States.
Location & Firm
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Address
-
341 Mason Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0324-2024
- Event ID
- 93929
- Recall initiation date
- February 9, 2024
- Center classification date
- February 13, 2024
- Code info
- Lot #: T04680, Exp. Date 6/2024
- More code info
- —