Agency classClass IIOur severity:Severe FDA (Drugs)·D-0302-2019·Announced 2018-12-19

Westminster Irbesartan Tablets Recalled Due to NDEA Impurity Traces

Westminster Pharmaceuticals is recalling specific lots of Irbesartan Tablets because FDA testing found traces of NDEA impurity.

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 health risks.

Plain-English summary

Westminster Pharmaceuticals, LLC is recalling specific lots of Westminster Irbesartan Tablets, USP 300 mg. The affected products are available in 30-count and 90-count bottles and were distributed nationwide. The recall involves 3,976 bottles with specific batch numbers and expiration dates listed in the agency's structured data.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of traces of NDEA impurity in the specific lots of Irbesartan.

Consumers who have these specific products should stop using them and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product: Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-121-01; b) 90 count bottle NDC 69367-121-03
Manufacturer: Westminster Pharmaceuticals Llc
Category: Drug — Prescription Medication
Hazard: ndeA-impurity
Affected units: 3,976

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)

Batch Numbers: a) B162008A Exp. 09/30/2019
C162002A Exp. 02/29/2020
b) B162008B Exp. 09/30/2019
C162002B Exp. 02/29/2020

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Westminster Pharmaceuticals Llc 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 · Westminster Pharmaceuticals Llc

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Westminster Irbesartan Tablets Recalled Due to NDEA Impurity
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Westminster Irbesartan Tablets Recalled Due to NDEA Impurity Traces
FDA (Drugs) · 2018-12-19
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Same hazard · ndeA impurity