Actavis Pharma Inc recalls Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle,…

Recall date

March 16, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1060-2016

FDA classification

Class III

Brand / firm

Actavis Pharma Inc

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

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).

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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