Aidarex Pharmaceuticals LLC recalls Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG:…

Recall date

June 1, 2016

Source

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

Recall number

D-1061-2016

FDA classification

Class III

Brand / firm

Aidarex Pharmaceuticals LLC

Sold / distributed

Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.

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

What was recalled

Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: Hi-Tech Pharmacal Co., Inc., Amityville, NY, 11701, NDC a) 33261-0910-01, b) 33261-0614-01