Recalls / Class II
Class IID-220-2013
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
- Brand name
- Ciprofloxacin
- Generic name
- Ciprofloxacin
- Active ingredient
- Ciprofloxacin Hydrochloride
- Route
- Oral
- NDCs
- 0143-9927, 0143-9928, 0143-9929
- FDA application
- ANDA076558
- Affected lot / code info
- Lot #: CB222A, Exp 06/16
Why it was recalled
Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.
Recalling firm
- Firm
- West-ward Pharmaceutical Corp.
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 465 Industrial Way W, Eatontown, New Jersey 07724-2209
Distribution
- Quantity
- 7,136 units
- Distribution pattern
- GA, AR
Timeline
- Recall initiated
- 2013-02-06
- FDA classified
- 2013-03-27
- Posted by FDA
- 2013-04-03
- Terminated
- 2014-08-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-220-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.