Defective Container: powder may leak out of the pouch
InvaGen Pharmaceuticals
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Defective Container; actuator may improperly function and affect dose delivery.
Presence of Particulate Matter.
Presence of Particulate Matter.
Presence of Particulate Matter.
Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
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.
Failed impurities/degradation specifications: Failure to water content and impurity
Failed Dissolution Specifications; during stability testing
Failed Dissolution Specifications; during stability testing