Home / Recalls / Sciegen Pharmaceuticals Inc / D-0269-2019

D-0269-2019 Class II Terminated

Recalled by Sciegen Pharmaceuticals Inc — Hauppauge, NY

Recall Details

Product Type
Drugs
Report Date
November 28, 2018
Initiation Date
October 29, 2018
Termination Date
September 25, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
5,989 HDPE

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.

Distribution Pattern

Nationwide

Code Information

69367-121-01 Irbesartan 300mg Tablets, 30 count bottle B162008A Sep-19 C162002A Feb-20 69367-121-03 Irbesartan 300mg Tablets, 90 count bottle B162008B Sep-19 C162002B Feb-20

Other recalls by Sciegen Pharmaceuticals Inc

  • D-0354-2023 Class III — Gabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by (February 17, 2023)
  • D-0271-2019 Class II — GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b (October 29, 2018)
  • D-0268-2019 Class II — Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120 (October 29, 2018)
  • D-0267-2019 Class II — Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-0 (October 29, 2018)
  • D-0270-2019 Class II — GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by S (October 29, 2018)
  • D-0272-2019 Class II — GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) (October 29, 2018)