Reported Feb 12, 2014 · Terminated
Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Manufactured in Czech Republic by: Teva Czech…
Teva Pharmaceuticals USA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Teva Pharmaceuticals USA · 425 Privet Rd · Horsham, PA · 19044-1220
Is this the product you have?
- Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only
- Manufactured in Czech Republic byTeva 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)
- Lot codes and dates
Lot # 6A201018VAExp. 01/14
- Amount recalled
- 112,800 tablets
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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