FDA-Drug2016-07-06Class III

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

Aidarex Pharmaceuticals LLC
Hazard

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

Sold states
Nationwide
Affected count
599 bottles
Manufactured in
595 N Smith Ave Ste B, Corona, CA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1061-2016

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