The Recall Desk
SevereFDA (Drugs)·D-0267-2019·Announced 2018-11-28

Sciegen Recalls Irbesartan Tablets Due to NDEA Impurity

Sciegen Pharmaceuticals is recalling Westminister Irbesartan Tablets because FDA testing found the impurity N-nitrosodimethylamine (NDEA).

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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric for significant potential health risks.

Plain-English summary

Sciegen Pharmaceuticals Inc is recalling Westminister Irbesartan Tablets, USP, 75 mg. The recall includes 30-count and 90-count bottles of the prescription medication. The product was manufactured by Sciegen Pharmaceuticals Inc and distributed nationwide.

The recall was initiated because FDA laboratory testing confirmed the presence of an impurity, N-nitrosodimethylamine (NDEA), in the product. This is a Class II recall, indicating a situation in which there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments or next steps.

The recalled product

Product
Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC 69367-119-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc Hauppauge, NY 11755 Manufactured for Westminister Pharmaceuticals LLC Olive Branch, MS 20854 Made in
Manufacturer
Sciegen Pharmaceuticals Inc
Category
Drug — Prescription Medication
Hazard
Affected units
2,977

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 (3)

  • 69367-119-01 Irbesartan 75mg Tablets
  • 30 count bottle B160002A Sep-19 69367-119-03 Irbesartan 75mg Tablets
  • 90 count bottle B160002B Sep-19

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Sciegen Pharmaceuticals 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 6 products in this recall →

Related recalls

Same manufacturer · Sciegen Pharmaceuticals Inc

See all →

Same hazard · nitrosamine impurity

See all →