InvaGen Pharmaceuticals recalls
FDA enforcement reports naming InvaGen Pharmaceuticals, Inc. as the recalling firm.
- Recall reports
- 11
- Class I (serious)
- 1
- Most recent report
- Jan 17, 2024
- Jan 17, 2024Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manuf…Drug · InvaGen Pharmaceuticals, Inc.Defective Container: powder may leak out of the pouchClass I
- May 27, 2020Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pha…Drug · InvaGen Pharmaceuticals, Inc.Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.Class III
- Jul 10, 2019Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation…Drug · InvaGen Pharmaceuticals, Inc.Defective Container; actuator may improperly function and affect dose delivery.Class III
- Apr 24, 2019Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use…Drug · InvaGen Pharmaceuticals, Inc.Presence of Particulate Matter.Class II
- Apr 24, 2019Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single Do…Drug · InvaGen Pharmaceuticals, Inc.Presence of Particulate Matter.Class II
- Apr 24, 2019Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use…Drug · InvaGen Pharmaceuticals, Inc.Presence of Particulate Matter.Class II
- Oct 17, 2018Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Ci…Drug · InvaGen Pharmaceuticals, Inc.Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.Class III
- Sep 26, 2018Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 690…Drug · InvaGen Pharmaceuticals, Inc.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.Class III
- Apr 18, 2018Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla LtdDrug · InvaGen Pharmaceuticals, Inc.Failed impurities/degradation specifications: Failure to water content and impurityClass III
- Apr 11, 2018buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-…Drug · InvaGen Pharmaceuticals, Inc.Failed Dissolution Specifications; during stability testingClass III
- buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only,…
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