Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC 69367-121-03), Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755. Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA.
Reported: November 28, 2018 Initiated: October 29, 2018 #D-0269-2019
Product Description
Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC 69367-121-03), Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755. Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA.
Reason for Recall
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Details
- Recalling Firm
- Sciegen Pharmaceuticals Inc
- Units Affected
- 5,989 HDPE
- Distribution
- Nationwide
- Location
- Hauppauge, NY
Frequently Asked Questions
What product was recalled? ▼
Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC 69367-121-03), Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755. Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA.. Recalled by Sciegen Pharmaceuticals Inc. Units affected: 5,989 HDPE.
Why was this product recalled? ▼
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 28, 2018. Severity: Moderate. Recall number: D-0269-2019.
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