Par Sterile Products LLC

3 FDA enforcement actions

3 Total Recalls

1 Class I

2 Class II

0 Class III

Firm Details

Product Types: drug
States: MI

All Recalls

Class I: Dangerous 03/04/2024 drug

Presence of Particulate Matter.
Class II: Risk 01/11/2024 drug

Superpotent Drug: Assay from the 3-month and 6-month stability intervals exceeded the upper specification limit.
Class II: Risk 11/09/2021 drug

Crystallization: presence of white, crystalline product agglomeration observed in 2 vials during annual inspection of retain samples.

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.