Heritage Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity
Heritage Pharmaceuticals is recalling Losartan Potassium Tablets 50 mg because FDA testing 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 under the rubric for drug recalls involving potential health risks.
Plain-English summary
Heritage Pharmaceuticals, Inc. is recalling Losartan Potassium Tablets USP 50 mg, 90 film coated tablets (NDC 23155-645-09). The affected product was manufactured by Vivimed Life Sciences Private Limited in India for Heritage Pharmaceuticals, Inc. in East Brunswick, NJ.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of the impurity N-Methylnitrosobutyric acid (NMBA) in the finished product at levels above the interim acceptable daily intake level at the manufacturer.
The recall involves 34,403 bottles distributed nationwide. The specific lots affected are CLO17009B (exp 11/2019), CLO17010A (exp 11/2019), and CLO18023A (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 Heritage Pharmaceuticals at 1-866-901-DRUG (3784) for instructions.
The recalled product
- Product
- Losartan Potassium Tablets USP 50 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
- Hazard
- Affected units
- 34,403
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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