Westminister Irbesartan Tablets recall: Impurity Out of Spec
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…
Why was Westminister Irbesartan Tablets recalled?
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
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?
69367-119-01 Irbesartan 75mg Tablets, 30 count bottle B160002A Sep-19 69367-119-03 Irbesartan 75mg Tablets, 90 count bottle B160002B Sep-19
- 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…
- Recalling firm
- Sciegen Pharmaceuticals Inc
- Quantity
- 2,977 HDPE bottles
- Distribution
- Nationwide
- Recall date
- November 28, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)