CIPLA: Drug Recall

Recall #D-1283-2022 · 07/14/2022

Class II: Risk

Recall Details

Recall Number: D-1283-2022
Classification: Class II
Product Type: Drug
Recalling Firm: CIPLA
Status: Terminated
Date Initiated: 07/14/2022
Location: Warren, NJ, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 8,136 bottles

Reason for Recall

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.

Product Description

Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limited., L-32, 33, 34, Verna Industrial area, Verna - Goa, 403722, India; Mfd. for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-341-35.

Distribution Pattern

Nationwide in the USA

Other Recalls by CIPLA

Class II: Risk 09/29/2022

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

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

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

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

Lack of Assurance of Sterility: Complaints received of defective container closure.

View all recalls by CIPLA →

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.