Ciprofloxacin Tablet, Film Coated
FDA Recall NDC 16571-413
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 16571-413). A significant event, classified as Class III, was initiated on Mar 09, 2012 by Rising Pharma Holdings, Inc.. The reported reason for this action was: "Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels."
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 III Terminated
Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.
Mar 09, 2012
Jul 25, 2012
4,848 bottles
Recall Profile & Regulatory Data
Event ID
51880
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Pack Pharmaceuticals
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jul 19, 2012
Product Description
Ciprofloxacin Tablets, USP, 500 mg, Rx Only, 100 Tablets per Bottle, Manufactured in India by: Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Ltd.), Mumbai - 400 030, Distributed by: PACK Pharmaceuticals, LLC, Buffalo Grove, IL 60089, NDC 16571-412-10.
Batch or Lot Expiration Information
Lot# : : PUB1040, Exp 08/2015
Affected Packages Involved in this Recall
16571-411-10Product
16571-412-10Product
16571-412-50Product
16571-413-05Product
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.
