Home / Recalls / Sciegen Pharmaceuticals Inc / D-0272-2019

D-0272-2019 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
30,194 HDPE bottles

Product Description

GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.

Reason for Recall

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Distribution Pattern

Nationwide

Code Information

60429-642-30 Irbesartan 300mg Tablets, 30 Count Bottle GS019036 Sep-19 GS019073 Sep-19 GS021472 Nov-19 GS021530 Nov-19 GS022234 Feb-20 60429-642-90 Irbesartan 300mg Tablets, 90 Count Bottle B162009 Sep-19 B162010 Sep-19 B162011 Sep-19 B162012 Nov-19 B162013 Nov-19 B162014 Nov-19 B162015 Nov-19 C162001 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-0269-2019 Class II — Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69 (October 29, 2018)