CIPLA

11 FDA enforcement actions

11 Total Recalls

0 Class I

11 Class II

0 Class III

Firm Details

Product Types: drug
States: NJ

All Recalls

Class II: Risk 09/29/2022 drug

Lack of Assurance of Sterility: environmental monitoring failure.
Class II: Risk 09/15/2022 drug

Lack of Assurance of Sterility
Class II: Risk 08/22/2022 drug

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class II: Risk 08/22/2022 drug

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class II: Risk 08/02/2022 drug

Lack of Assurance of Sterility: Complaints received of defective container closure.
Class II: Risk 07/14/2022 drug

Lack of Assurance of Sterility: customer complaint for defective container where breakage of the protective cap exposes tip of eye drop which could compromise sterility.
Class II: Risk 06/10/2021 drug

CGMP Deviations
Class II: Risk 12/17/2020 drug

Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class II: Risk 12/17/2020 drug

Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class II: Risk 12/17/2020 drug

Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline
Class II: Risk 12/14/2020 drug

cGMP deviations: Vials may not be sealed correctly affecting sterility.

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.