Agency classClass IIOur severity:Severe FDA (Drugs)·D-1102-2020·Announced 2020-04-15

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.

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 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
Hazard: nitrosamine-impurity
cancer-risk

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.

See all 3 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · nitrosamine impurity