FDA recall D-0042-2015

Product

Ciprofloxacin 500 mg tablets, 20 count bottle, Rx only, Packaged by Aidarex Pharmacecuticals LLC, MFG: Unique Pharmaceutical Laboratories, Mumbai, India

Reason for recall

Presence of Foreign Tablets/Capsules: Tramodol 50 mg tablet has been found in a bottle of Ciprofloxacin 500 mg

Distribution

Nationwide in US: FL, SC, WA, WV, IN, AL, VA, MS

Key facts

Status

Terminated

Initiation date

2014-05-22

Report date

2014-10-29

Termination date

2014-11-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Corona, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0042-2015