Status
Terminated
Drug Enforcement D-0039-2024
Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
Classification
Class III
Report Date
October 11, 2023
Termination Date
July 16, 2024
Product Information
- Product description
- HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC#: 68084-447-01; Individual Dose NDC: 68084-447-11
- Product quantity
- 3,344 cartons
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of Specification results in the repackaged product for impurities at the 12-month time point.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Amerisource Health Services LLC
- Address
-
2550 John Glenn Ave Ste A, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0039-2024
- Event ID
- 93089
- Recall initiation date
- September 1, 2023
- Center classification date
- October 5, 2023
- Code info
- Lot#: 1007002, Exp 12/31/2023
- More code info
- —