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.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot #: : PUB1040, Exp 08/2015
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Pack Pharmaceuticals
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

Lot #: : PUB1040, Exp 08/2015

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1422-2012

Related Recalls

Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.

Sep 9, 2013 Compounded Drugs Nationwide View Details →

Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.

Sep 9, 2013 Other Drugs Nationwide View Details →

Defective Container: Stability samples of both products were noted to have some white solid product residue, identified as dried active ingredients along with the preservative, on the exterior of the bottles.

Sep 9, 2013 Compounded Drugs Nationwide View Details →