Home / Recalls / InvaGen Pharmaceuticals, Inc. / D-0619-2018

D-0619-2018 Class III Terminated

Recalled by InvaGen Pharmaceuticals, Inc. — Hauppauge, NY

Recall Details

Product Type
Drugs
Report Date
April 11, 2018
Initiation Date
March 15, 2018
Termination Date
September 15, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788

Reason for Recall

Failed Dissolution Specifications; during stability testing

Distribution Pattern

Nationwide

Code Information

a) Lot I1606609 and Lot I1606610 Exp. Date 05/2018; Lot I1610639 Exp. Date 09/2018 b) Lot #I1606610 Exp Date 05/2018; Lot I1607847 and Lot I1607845 Exp Date 06/2018; Lot I1610639 Exp Date 09/2018

Other recalls by InvaGen Pharmaceuticals, Inc.

  • D-0220-2024 Class I — Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only (November 17, 2023)
  • D-1272-2020 Class III — Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exe (May 14, 2020)
  • D-1454-2019 Class III — Testosterone Topical Solution 30mg of testosterone per pump actuation * each act (June 12, 2019)
  • D-1125-2019 Class II — Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscu (March 22, 2019)
  • D-1123-2019 Class II — Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscu (March 22, 2019)
  • D-1124-2019 Class II — Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Si (March 22, 2019)
  • D-0012-2019 Class III — Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured (October 3, 2018)
  • D-1212-2018 Class III — Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle ( (September 6, 2018)
  • D-0618-2018 Class III — buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx (March 15, 2018)
  • D-0698-2018 Class III — Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., V (March 5, 2018)