Teva Recalls Hydralazine HCL Tablets Due to Impurity Concerns
Teva Pharmaceuticals USA is recalling specific lots of Hydralazine HCL 50 mg tablets because they may fail impurity specifications throughout their shelf life.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which the rubric associates with moderate severity when no specific hospitalizations or severe injuries are reported, fitting the criteria for minor labeling errors or low-risk contamination/precautionary recalls.
Plain-English summary
Teva Pharmaceuticals USA is recalling 112,800 tablets of Hydralazine HCL Tablets, USP, 50 mg. The affected product is distributed nationwide and is identified by Lot # 6A201018VA with an expiration date of 01/14. The tablets are manufactured in the Czech Republic by Teva Czech Industries s.r.o. and distributed by Goldline Laboratories.
The recall was initiated because there is a potential for the tablets to be out of specification for impurities throughout their shelf life. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Patients who have been prescribed this specific lot of Hydralazine HCL should contact their healthcare provider or pharmacist for guidance on alternative treatment options. The product is prescription-only, so consumers should not attempt to self-manage the switch without professional advice.
The recalled product
- 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
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 112,800
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 6A201018VA
- Exp. 01/14.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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