Central Islip, NY, United States
InvaGen Pharmaceuticals, Inc. recalls
8 recalls recorded since 2018, most recently on 17 November 2023. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls8
Ongoing (FDA)0
Terminated or completed8
Class I (FDA)1
Completed Class I Drugs
- Recall started
- 17 November 2023
- Reason
- Defective Container: powder may leak out of the pouch
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0220-2024
- Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for: Cipla USA, Inc., War
Terminated Class III Drugs
- Recall started
- 14 May 2020
- Terminated
- 31 August 2020
- Reason
- Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
- Distribution
- Nationwide in the U.S.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1272-2020
- Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788, NDC 76282-405-05.
Terminated Class III Drugs
- Recall started
- 12 June 2019
- Terminated
- 28 January 2021
- Reason
- Defective Container; actuator may improperly function and affect dose delivery.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1454-2019
- Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution Total contents: 110 mL to deliver 90 mL, Manufactured by: Cipla Ltd, Verna Goa, India Manufactured for: C
Terminated Class II Drugs
- Recall started
- 22 March 2019
- Terminated
- 16 August 2022
- Reason
- Presence of Particulate Matter.
- Distribution
- Nationwide in the U.S.A.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1125-2019, D-1123-2019, D-1124-2019
- Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Saw
- Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Saw
- Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite
Terminated Class III Drugs
- Recall started
- 3 October 2018
- Terminated
- 13 July 2021
- Reason
- Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
- Distribution
- Nationwide with the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0012-2019
- Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 36909
Terminated Class III Drugs
- Recall started
- 6 September 2018
- Terminated
- 22 October 2020
- Reason
- Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
- Distribution
- Product was distributed to 14 major distributors who shipped the product U.S.A. nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1212-2018
- Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68
Terminated Class III Drugs
- Recall started
- 15 March 2018
- Terminated
- 15 September 2021
- Reason
- Failed Dissolution Specifications; during stability testing
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0619-2018, D-0618-2018
- 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
- buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceutical
Terminated Class III Drugs
- Recall started
- 5 March 2018
- Terminated
- 20 January 2021
- Reason
- Failed impurities/degradation specifications: Failure to water content and impurity
- Distribution
- U.S.A. nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0698-2018
- Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.