InvaGen Pharmaceuticals, Inc. Recalls

All product recalls associated with InvaGen Pharmaceuticals, Inc..

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Recall Summary

Total Recalls

11

Past Year

0

Class I (Serious)

1

Most Recent

Nov 2023

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–11 of 11 recalls

Vigabatrin Oral Solution (InvaGen) – Defective Container (2023)

Defective Container: powder may leak out of the pouch

Class IHigh

FDANov 17, 2023Nationwide• InvaGen Pharmaceuticals, Inc.

Gabapentin Tablets (InvaGen) – Impurity Test Failure (2020)

Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.

Class IIILow

FDAMay 14, 2020Nationwide• InvaGen Pharmaceuticals, Inc.

Testosterone Topical Solution (InvaGen) – Defective Container (2019)

Defective Container; actuator may improperly function and affect dose delivery.

Class III

Low

FDAJun 12, 2019Nationwide• InvaGen Pharmaceuticals, Inc.

Testosterone Cypionate Injection (InvaGen) – Particulate Matter (2019)

Presence of Particulate Matter.

Class IIModerate

FDAMar 22, 2019Nationwide• InvaGen Pharmaceuticals, Inc.

Testosterone Cypionate Injection (InvaGen) – Particulate Matter (2019)

Presence of Particulate Matter.

Class IIModerate

FDAMar 22, 2019Nationwide• InvaGen Pharmaceuticals, Inc.

Testosterone Cypionate Injection (InvaGen) – Particulate Matter (2019)

Presence of Particulate Matter.

Class IIModerate

FDAMar 22, 2019Nationwide• InvaGen Pharmaceuticals, Inc.

Amlodipine Besylate Tablets (InvaGen) – Subpotent Drug (2018)

Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.

Class IIILow

FDAOct 3, 2018Nationwide• InvaGen Pharmaceuticals, Inc.

Bupropion ER Tablets (InvaGen) – impurity issue (2018)

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 IIILow

FDASep 6, 2018Nationwide• InvaGen Pharmaceuticals, Inc.