February 2013 FDA Recall Ciprofloxacin by West-ward Pharmaceutical Corp.
D-220-2013 - Presence of Foreign Substance(s
This Class II drug recall was voluntarily initiated by West-ward Pharmaceutical Corp. on February 6, 2013 for the product Ciprofloxacin. The FDA reported the reason for recall as presence of foreign substance(s). The product was distributed in GA, AR and the recall is currently terminated.
Recall Number: D-220-2013
Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.
02-06-2013
04-03-2013
7,136 units
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
West-ward Pharmaceutical Corp.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
GA, AR
08-04-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : CB222A, Exp 06/16
