Teva Recalls Losartan Potassium Tablets Due to Impurity Detection
Teva Pharmaceuticals USA is recalling bulk Losartan Potassium Tablets because an impurity was detected in the active pharmaceutical ingredient.
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
Teva Pharmaceuticals USA is recalling Losartan Potassium Tablets, USP 25 mg, Bulk, Rx only. The product is intended for further manufacturing, packing, or repackaging only and was manufactured by Arrow Pharma (Malta) Ltd. in Birzebbugia, Malta.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, an impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) was detected in the active pharmaceutical ingredient (API) used to manufacture the finished products.
The bulk product was distributed to one re-packager in California. The affected lots are 1207344A (expiration date 06/2020), 1207343A, and 1207342A (expiration date 07/2020). The National Drug Code (NDC) for the product is 0591-3745-00.
The recalled product
- Product
- LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia Malta NDC 0591-3745-00
- Manufacturer
- Teva Pharmaceuticals USA
- 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 (5)
- Lots 1207344A
- exp. date 06/2020
- 1207343A
- 1207342A
- exp. date 07/2020
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 3 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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