MYLAN PHARMACEUTICALS INC

7 FDA enforcement actions

7 Total Recalls

3 Class I

4 Class II

0 Class III

Firm Details

Product Types: drug
States: WV

All Recalls

Class II: Risk 02/25/2025 drug

Failed Dissolution Specifications - low dissolution results
Class I: Dangerous 07/05/2022 drug

Labeling: Missing label: Label missing from some prefilled pens.
Class I: Dangerous 04/12/2022 drug

Labeling: Missing label on the vial
Class II: Risk 04/07/2022 drug

Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
Class II: Risk 04/01/2022 drug

Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.
Class II: Risk 01/21/2022 drug

cGMP deficiencies
Class I: Dangerous 01/05/2022 drug

Labeling: Missing Label: label missing from some Semglee prefilled pens.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.