AvKARE Recalls Losartan Potassium Tablets Due to Impurity
AvKARE Inc. is recalling Losartan Potassium Tablets 50 mg because an impurity, N-Methylnitrosobutyric acid (NMBA), was identified.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for drug recalls involving impurities.
Plain-English summary
AvKARE Inc. is recalling Losartan Potassium Tablets USP 50 mg, 50 Tablets (5x10) Unit Dose boxes (NDC 50268-517-15). The recall is due to Current Good Manufacturing Practice (CGMP) deviations, specifically the presence of an impurity identified as N-Methylnitrosobutyric acid (NMBA).
The affected lots are 20961 (Expiration 09/2019) and 20477 (Expiration 08/2019). The product was distributed nationwide.
Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15
- Manufacturer
- AVKARE Inc.
- Category
- Drug — Prescription Medication
- Hazard
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)
- Lots: 20961 Exp. 09/2019
- 20477 Exp. 08/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by AVKARE Inc. 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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