March 2012 FDA Recall Ciprofloxacin by Pack Pharmaceuticals
D-1422-2012 - Labeling Illegible
This Class III drug recall was voluntarily initiated by Pack Pharmaceuticals on March 9, 2012 for the product Ciprofloxacin. The FDA reported the reason for recall as labeling illegible. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1422-2012
Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.
03-09-2012
07-25-2012
4,848 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Pack Pharmaceuticals
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.
Nationwide
07-19-2012
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
