Class II
Terminated
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).
- Company
- Teva Pharmaceuticals Usa
- Recall Initiated
- December 18, 2013
- Posted
- February 12, 2014
- Recall Number
- D-1075-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 112,800 tablets
- Firm Location
- Horsham, PA, United States
Reason for Recall
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Distribution
Nationwide
Lot / Code Info
Lot # 6A201018VA; Exp. 01/14.
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