Ciprofloxacin Tablet, Film Coated
FDA Recall NDC 0143-9928
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Ciprofloxacin (NDC 0143-9928). A significant event, classified as Class II, was initiated on Feb 06, 2013 by Hikma Pharmaceuticals Usa Inc.. The reported reason for this action was: "Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.
Feb 06, 2013
Apr 03, 2013
7,136 units
Recall Profile & Regulatory Data
Event ID
64100
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
West-ward Pharmaceutical Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
GA, AR
Termination Date
Aug 04, 2014
Product Description
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
Affected Packages Involved in this Recall
0143-9927-01Product
0143-9927-05Product
0143-9927-30Product
0143-9928-01Product
0143-9928-05Product
0143-9928-30Product
0143-9929-01Product
0143-9929-50Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
