Drug Enforcement D-220-2013

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

Status

Terminated

Classification

Class II

Report Date

April 3, 2013

Termination Date

August 4, 2014

Product Information

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
Product quantity
7,136 units
Reason for recall
Presence of Foreign Substance(s): A complaint was received for a rubber-like material in a 500 mg Ciprofloxacin tablet.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
GA, AR

Location & Firm

Recalling firm
West-ward Pharmaceutical Corp.
Address
465 Industrial Way W

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-220-2013
Event ID
64100
Recall initiation date
February 6, 2013
Center classification date
March 27, 2013
Code info
Lot #: CB222A, Exp 06/16
More code info
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