FDA recall D-1328-2022

CIPLA · Class II · drug

Product

Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status: Terminated
Initiation date: 2022-08-02
Report date: 2022-08-17
Termination date: 2023-11-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Warren, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1328-2022