The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0505-2019·Announced 2019-02-27

Torrent Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

Torrent Pharma Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets because FDA testing found the impurity N-nitrosodimethylamine (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, which corresponds to a Severe severity score under the rubric, particularly given the presence of a known carcinogenic impurity (NDEA) above acceptable limits.

Plain-English summary

Torrent Pharma Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg, in 90-count and 1000-count bottles. The recall affects 18,780 bottles distributed nationwide in the United States and Puerto Rico. The specific lots involved are Lot BP02C008 (expiring 03/2019) for the 90-count bottles and Lots BEF7D006 (expiring 03/2020) for the 1000-count bottles.

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 levels of NDEA were found to be above the interim acceptable daily intake level of 0.083 parts per million.

Consumers and healthcare providers should stop using the affected medication and contact their healthcare provider for guidance on alternative treatments. The recalled products should be returned to the pharmacy or point of purchase for disposal or credit.

The recalled product

Product
LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle (NDC: 13668-116-90), b) 1000-count bottle (NDC: 13668-116-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
Manufacturer
Torrent Pharma Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
18,780

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 (6)

  • Count
  • lots
  • expiry: [90-count bottle] Lot BP02C008
  • exp 03/2019
  • [1000-count bottle] Lots BEF7D006
  • exp 03/2020

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 →

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