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FDAMarch 16, 2016drug

Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophthalmic Use Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701, NDC: a) 50383-0282-02, b) 50383-282-05, c) 50383-0282-10

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

The hazard

Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).

What to do

FDA enforcement status: Terminated

Brands named

actavis pharmaactavis

UPCs

5038302820250383028210

Recall history

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

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Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophthalmic Use Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701, NDC: a) 50383-0282-02, b) 50383-282-05, c) 50383-0282-10 — Recall Details · AllClear