Westminster Irbesartan Tablets recall: Impurity Out of Spec
Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster…
Why was Westminster Irbesartan Tablets recalled?
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Batch Numbers: a) B162008A Exp. 09/30/2019, C162002A Exp. 02/29/2020; b) B162008B Exp. 09/30/2019, C162002B Exp. 02/29/2020
- Product
- Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster…
- Recalling firm
- Westminster Pharmaceuticals Llc
- Quantity
- 3976 bottles
- Distribution
- Nationwide.
- Recall date
- December 19, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)