Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: Hi-Tech Pharmacal Co., Inc., Amityville, NY, 11701, NDC a) 33261-0910-01, b) 33261-0614-01

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Lot # : a) 44704-1, 44899-1, 45153-1, 45387-1 Exp. 10/2016, 45449-1, 45801-1, 47647-1, Exp. 02/2017 b) 40990-1 Exp: 05/2016, 45960-1 Exp. 08/2016, 45316-1, 45961-1 Exp. 09/2016
  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:
Aidarex Pharmaceuticals LLC
Reason for Recall:
Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Ciprofloxacin OPTH 0.3% SOL, generic for: Ciloxan, Rx Only, 2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: Hi-Tech Pharmacal Co., Inc., Amityville, NY, 11701, NDC a) 33261-0910-01, b) 33261-0614-01

Product Codes/Lot Numbers:

Lot # : a) 44704-1, 44899-1, 45153-1, 45387-1 Exp. 10/2016, 45449-1, 45801-1, 47647-1, Exp. 02/2017 b) 40990-1 Exp: 05/2016, 45960-1 Exp. 08/2016, 45316-1, 45961-1 Exp. 09/2016

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1061-2016

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