FDARecalled Feb 14, 2024 · #D-0320-2024
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Un...
Hazard
Class III — low health risk
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Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point. Classification: Class III Distribution: Nationwide in the USA
Product details
- Product
- HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11
- Type
- Drugs
- Manufacturer
- Amerisource Health Services LLC
- Model numbers
- 1012275
- UPCs
- —