InvaGen Pharmaceuticals, Inc.

FDA Regulatory Profile

Summary

Total Recalls
11 (1 Class I)
510(k) Clearances
0
Inspections
20
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0220-2024Class IVigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: INovember 17, 2023
D-1272-2020Class IIIGabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals,May 14, 2020
D-1454-2019Class IIITestosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 June 12, 2019
D-1125-2019Class IITestosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use only, 10 mL March 22, 2019
D-1123-2019Class IITestosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use only, 10 mL March 22, 2019
D-1124-2019Class IITestosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single Dose, Rx Only, March 22, 2019
D-0012-2019Class IIIAmlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., VerOctober 3, 2018
D-1212-2018Class IIIBupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), MSeptember 6, 2018
D-0619-2018Class IIIbuPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 1March 15, 2018
D-0618-2018Class IIIbuPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured March 15, 2018
D-0698-2018Class IIIDecitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, ManMarch 5, 2018