FDA recall D-1061-2016

Product

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-06-01

Report date

2016-07-06

Termination date

2016-10-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Corona, CA, United States

Primary source

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