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FDAJuly 14, 2022drug

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

cipla

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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