Teva Recalls Losartan Potassium Tablets Due to NMBA Impurity
Teva Pharmaceuticals USA is recalling bulk Losartan Potassium Tablets 50 mg because an impurity, NMBA, was detected in the active pharmaceutical ingredient.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 injury or property damage reports or high-risk scenarios.
Plain-English summary
Teva Pharmaceuticals USA is recalling Losartan Potassium Tablets, USP 50 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 affected lots are 1195625A, 1195624A, and 1195623A, all with an expiration date of 03/2020.
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. Because this is a bulk product intended for further manufacturing, it is not directly available to consumers. Healthcare providers and pharmacies should check their inventory for these specific lot numbers and stop using them if found.
The recalled product
- Product
- LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00
- 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 (4)
- Lots 1195625A
- 1195624A
- 1195623A
- exp. date 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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