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 G
FDA recall notice · announced July 25, 2012 · Pack Pharmaceuticals
Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.
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.
Reason for recall
Labeling Illegible: Missing Label; The voluntary recall of the aforementioned batch of product is being initiated due to two bottles missing container labels.
Notes
Distribution: Nationwide
Lot/code information: Lot #: : PUB1040, Exp 08/2015
Quantity: 4,848 bottles
Status: Terminated
Products in this recall event:
- 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 03 (D-1422-2012)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.