Drug product
Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Manufactured in Czech Republic by: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0555-89 (carton) and 00182-0555-00 (single blister).
D-1075-2014
Product summary
- Event
- Event 67141
- Status
- Terminated
- Classification
- Class II
- Quantity
- 112,800 tablets
- Official record key
drug-enforcement:D-1075-2014
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 # 6A201018VA; Exp. 01/14.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification