Agency classClass IIOur severity:Severe FDA (Drugs)·D-0503-2019·Announced 2019-02-27

Torrent Pharma Recalls Losartan Potassium Tablets Due to NDEA Impurity

Torrent Pharma Inc. is recalling Losartan Potassium Tablets because FDA testing found the impurity NDEA above acceptable levels.

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, and the presence of NDEA, a probable human carcinogen, above acceptable levels constitutes a significant health risk warranting a Severe rating.

Plain-English summary

Torrent Pharma Inc. is recalling Losartan Potassium Tablets, USP, 25 mg, 90-count bottles (NDC: 13668-113-90). The recall involves 43,416 bottles of Lot 4O49C013 with an expiration date of 09/2019. These prescription-only medications were distributed nationwide in the United States and Puerto Rico.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of the impurity N-nitrosodimethylamine (NDEA) in the active pharmaceutical ingredient (API) used to manufacture the product. The detected levels of NDEA exceeded the interim acceptable daily intake level of 0.083 parts per million.

Consumers and healthcare providers should stop using the affected Losartan Potassium Tablets and contact their healthcare provider for alternative treatment options. The recalled product should be returned to the pharmacy or disposed of according to local regulations.

The recalled product

Product: LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
Manufacturer: Torrent Pharma Inc.
Category: Drug — Prescription Medication
Hazard: nde-impurity
carcinogen-exposure
Affected units: 43,416

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)

Count
lots
expiry: [90-count bottle] Lot 4O49C013
exp 09/2019

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 5 recalled by Torrent Pharma 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.

See all 5 products in this recall →

Same manufacturer · Torrent Pharma Inc.

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