FDA recall D-220-2013

West-ward Pharmaceutical Corp. · Class II · drug

Product

Ciprofloxacin Tablets USP, 500 mg, 100-count bottle, Rx only, Manufactured for West-ward Pharmaceutical Corp., Eatowntown, NJ 07724 by Hikma Pharmaceuticals, Amman, Jordan, NDC 0143-9928-01

Reason for recall

Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.

Distribution

GA, AR

Key facts

Status
Terminated
Initiation date
2013-02-06
Report date
2013-04-03
Termination date
2014-08-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Eatontown, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-220-2013