Invagen Pharmaceuticals, Inc.

25 FDA enforcement records linked to this company.

• recall — Class I2024-01-17

  Defective Container: powder may leak out of the pouch

• recall — Class III2020-05-27

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

• 4832019-12-06

  Batch production and Batch Control Record Requirements

• 4832019-12-06

  Written in-process control procedures

• 4832019-12-06

  Testing and release for distribution

• recall — Class III2019-07-10

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

• recall — Class II2019-04-24

  Presence of Particulate Matter.

• recall — Class II2019-04-24

  Presence of Particulate Matter.

• recall — Class II2019-04-24

  Presence of Particulate Matter.

• recall — Class III2018-10-17

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

• recall — Class III2018-09-26

  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.

• 4832018-05-25

  Investigations of discrepancies, failures

• 4832018-05-25

  Failure to meet specifications

• 4832018-05-25

  Written program not followed

• 4832018-05-25

  Mix-up