🔍 RecallPedia

Mitomycin 0.02% Ophthalmic Solution, single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous
💊 Drugs Recalled: June 2, 2015 The Compounding Pharmacy of America Compounded Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    All lots distributed between November 2014 and May 2015; 06132014@45, 6/13/2015; 02032015@82, 2/3/2016; 03242015@26, 3/23/2016; 08142014@46, 8/14/2015; 07172014@54, 7/17/2015; 12032014@77, 12/3/2015; 03102015@23, 3/9/2016; 03042015@44, 3/3/2016
  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:
The Compounding Pharmacy of America
Reason for Recall:
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Classification:
Class I - Dangerous

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

Status:
terminated

Product Information

Full Description:

Mitomycin 0.02% Ophthalmic Solution, single dose dropper, Keep Frozen, The Compounding Pharmacy of America, Knoxville, TN

Product Codes/Lot Numbers:

All lots distributed between November 2014 and May 2015; 06132014@45, 6/13/2015; 02032015@82, 2/3/2016; 03242015@26, 3/23/2016; 08142014@46, 8/14/2015; 07172014@54, 7/17/2015; 12032014@77, 12/3/2015; 03102015@23, 3/9/2016; 03042015@44, 3/3/2016

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1581-2015

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