Teva Recalls Losartan Potassium Tablets Due to NMBA Impurity
Teva Pharmaceuticals USA is recalling bulk Losartan Potassium Tablets 100 mg because an impurity called NMBA was detected in the active 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 agency classification is FDA Class II, and the presence of a nitrosamine impurity (NMBA) in a pharmaceutical product represents a significant health risk, aligning with the 'Severe' criteria for significant injury reports or high-risk contamination.
Plain-English summary
Teva Pharmaceuticals USA is recalling bulk Losartan Potassium Tablets, USP 100 mg, NDC 0591-3747-00. The product is intended for further manufacturing, packing, or repackaging only and is not sold directly to consumers.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, an impurity known as 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 lot codes are 1178533A through 1178546A, all with an expiration date of 03/2020. Consumers should not use this product. Healthcare providers and pharmacies should check their inventory for these specific lot codes and stop dispensing them if found.
The recalled product
- Product
- LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3747-00
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
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 (14)
- 1178533A
- 1178534A
- 1178535A
- 1178536A
- 1178537A
- 1178538A
- 1178539A
- 1178540A
- 1178541A
- 1178542A
- 1178543A
- 1178544A
- 1178545A
- 1178546A exp 03/2020
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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