CLASS II Drug recall · Reported 3 Apr 2013 · FDA Enforcement Report
Ciprofloxacin Tablets USP, 500 mg recalled by West-ward Pharmaceutical
West-ward Pharmaceutical is recalling Ciprofloxacin Tablets USP, 500 mg, distributed in Arkansas, Georgia. The recall was initiated on 6 Feb 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-220-2013
- FDA event ID
- 64100
- Recalling firm
- West-ward Pharmaceutical, Eatontown, NJ
- Brand
- Ciprofloxacin
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Feb 2013
- FDA classified
- 27 Mar 2013
- Reported
- 3 Apr 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Antibiotics
Timeline
| 6 Feb 2013 | Recall initiated by company | |
| 27 Mar 2013 | Classified by FDA | +49 days |
| 3 Apr 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
GA, AR
Questions about this recall
Is Ciprofloxacin Tablets USP, 500 mg recalled?
Yes. West-ward Pharmaceutical recalled Ciprofloxacin Tablets USP, 500 mg on 6 Feb 2013. The recall is Class II and its status is Terminated. Recall number D-220-2013.
Why was it recalled?
Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.
Which lots are affected?
Lot #: CB222A, Exp 06/16
Where was it sold?
GA, AR
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Ciprofloxacin recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ciprofloxacin 3% and Dexamethasone 1% Otic Suspension recalled by SandozCiprofloxacin And Dexamethasone | Sandoz | Temperature Abuse | CA |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution USP, 3% as base, package recalledCiprofloxacin | FDC | Packaging Defects | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution USP, 3% as base, Sterile, package recalledCiprofloxacin | FDC | Sterility | Nationwide |
| Drug | CLASS II | Ciprofloxacin ophthalmic solution USP, 3% as base recalled by FDCCiprofloxacin | FDC | Packaging Defects | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution recalled by Mckesson Medical-SurgicalCiprofloxacin Hydrochloride | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |