Sciegen Pharmaceuticals Inc

FDA Regulatory Profile

Summary

Total Recalls
7
510(k) Clearances
0
Inspections
13
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0354-2023Class IIIGabapentin Tablets, USP 600 mg, 500 tablets per bottle, RX Only, Manufactured by ScieGen PharmaceutiFebruary 17, 2023
D-0268-2019Class IIWestminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-count bOctober 29, 2018
D-0267-2019Class IIWestminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count botOctober 29, 2018
D-0271-2019Class IIGSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NOctober 29, 2018
D-0272-2019Class IIGSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDOctober 29, 2018
D-0269-2019Class IIWestminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-cOctober 29, 2018
D-0270-2019Class IIGSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen PharmaceuticaOctober 29, 2018