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).
Reported: February 12, 2014 Initiated: December 18, 2013 #D-1075-2014
Product Description
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).
Reason for Recall
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 112,800 tablets
- Distribution
- Nationwide
- Location
- Horsham, PA
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Teva Pharmaceuticals USA. Units affected: 112,800 tablets.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 12, 2014. Severity: Moderate. Recall number: D-1075-2014.
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