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 under the rubric for significant potential health risks.
Plain-English summary
Heritage Pharmaceuticals, Inc. is recalling 3,697 bottles of Losartan Potassium Tablets USP 100 mg. The affected product is distributed nationwide and includes specific lot codes with expiration dates ranging from December 2019 to January 2020.
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 limit.
Consumers who have this medication should stop using it and contact their healthcare provider for guidance on alternative treatment options. The product is prescription-only and was manufactured by Vivimed Life Sciences Private Limited for Heritage Pharmaceuticals, Inc.
The recalled product
- Product
- Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only 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 Pharmaceut
- Manufacturer
- Heritage Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,697
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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