Drug product
Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech Republic By: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0554-89 (carton) and 00182-0554-00 (single blister).
D-1074-2014
Product summary
- Event
- Event 67141
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,249,700 tablets
- Official record key
drug-enforcement:D-1074-2014
Official wording
Reason: Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Code information: lot #14071112AA; Exp. 03/14. lot #14071112AB; Exp. 03/14. lot # 14071012BA; Exp. 03/14. lot #14071012BB; Exp 03/14.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification