Westminster Irbesartan Tablets Recalled Due to NDEA Impurity
Westminster Pharmaceuticals is recalling specific lots of Irbesartan tablets because FDA testing found traces of the NDEA impurity.
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 severity score under the rubric for drug recalls involving significant quality deviations.
Plain-English summary
Westminster Pharmaceuticals, LLC is recalling specific lots of Westminster Irbesartan Tablets, USP 75 mg. The recall involves 1,571 bottles of the medication, including 30-count and 90-count bottles, which were distributed nationwide.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of traces of the NDEA impurity in the affected lots. The specific batch numbers involved are B160002A and B160002B, both with an expiration date of 09/30/2019.
Consumers who have these specific lots of Irbesartan tablets 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 75 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 69367-119-01; b) 90 count bottle NDC 69367-119-03
- Manufacturer
- Westminster Pharmaceuticals Llc
- Category
- Drug — Prescription Medication
- Affected units
- 1,571
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 (2)
- Batch Numbers: a) B160002A Exp. 09/30/2019
- b) B160002B Exp. 09/30/2019
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.
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