Recalls / Class II
Class IID-1074-2014
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).
- Affected lot / code info
- lot #14071112AA; Exp. 03/14. lot #14071112AB; Exp. 03/14. lot # 14071012BA; Exp. 03/14. lot #14071012BB; Exp 03/14.
Why it was recalled
Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 1,249,700 tablets
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-12-18
- FDA classified
- 2014-02-04
- Posted by FDA
- 2014-02-12
- Terminated
- 2014-10-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1074-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.