Recall: D-1328-2022

Class II - Potentially Harmful

Class IIClassification

2022-08-02Initiated

TerminatedStatus

CIPLAFirm

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.