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 ScieGen Pharmaceuticals Inc Hauppauge, NY 11755 Manufactured for Westminister Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA
Reported: November 28, 2018 Initiated: October 29, 2018 #D-0267-2019
Product Description
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 ScieGen Pharmaceuticals Inc Hauppauge, NY 11755 Manufactured for Westminister 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
- 2,977 HDPE bottles
- Distribution
- Nationwide
- Location
- Hauppauge, NY
Frequently Asked Questions
What product was recalled? ▼
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 ScieGen Pharmaceuticals Inc Hauppauge, NY 11755 Manufactured for Westminister Pharmaceuticals LLC Olive Branch, MS 20854 Made in the USA. Recalled by Sciegen Pharmaceuticals Inc. Units affected: 2,977 HDPE bottles.
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-0267-2019.
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