Heritage Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity
Heritage Pharmaceuticals is recalling Losartan Potassium Tablets 100 mg because FDA labs found an impurity above acceptable levels.
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 (4) under the rubric, as it involves a potential health risk with an impurity exceeding acceptable daily intake levels.
Plain-English summary
Heritage Pharmaceuticals, Inc. is recalling Losartan Potassium Tablets USP 100 mg, 90 film coated tablets. The product was manufactured by Vivimed Life Sciences Private Limited in India for Heritage Pharmaceuticals, Inc. in East Brunswick, NJ. The recall involves 25,220 bottles distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of an impurity, N-Methylnitrosobutyric acid (NMBA), in the finished product at levels above the interim acceptable daily intake level at the manufacturer.
Affected lots include CLO17012A (exp 11/2019), CLO17013A (exp 11/2019), CLO18002A (exp 01/2020), CLO18020A (exp 04/2020), CLO18021A (exp 04/2020), and CLO18022A (exp 04/2020). Consumers should check their medication for these lot numbers and expiration dates. If the medication matches the recalled lots, consumers should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram - 603 110, Tamilnadu, India. Manufactured for: Heritage Pharmaceuticals Inc.,
- Manufacturer
- Heritage Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 25,220
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Heritage Pharmaceuticals, 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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