🔍 RecallPedia

MEGA-BURN III Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

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

What Should You Do?

  1. Check if you have this product:
    All lots distributed between November 2014 and May 2015; 03022015@28, 5/31/2015; 04152015@17, 7/14/2015; 04152015@44, 7/14/2015; 02272015@62, 5/28/2015; 03032015@25, 6/1/2015; 03122015@89, 6/10/2015; 03162015@58, 6/14/2015; 03182015@28, 6/16/2015; 03302015@26, 6/28/2015; 04062015@65, 7/5/2015; 04142015@45, 7/13/2015; 04172015@46, 7/16/2015; 04242015@27, 7/23/2015; 04292015@31, 7/28/2015; 04292015@81, 7/28/2015; 5082015@63, 8/6/2015; 04302015@9, 7/29/2015; 05112015@30, 8/9/2015; 5072015@14, 8/5/2015
  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:
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:

MEGA-BURN III Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN

Product Codes/Lot Numbers:

All lots distributed between November 2014 and May 2015; 03022015@28, 5/31/2015; 04152015@17, 7/14/2015; 04152015@44, 7/14/2015; 02272015@62, 5/28/2015; 03032015@25, 6/1/2015; 03122015@89, 6/10/2015; 03162015@58, 6/14/2015; 03182015@28, 6/16/2015; 03302015@26, 6/28/2015; 04062015@65, 7/5/2015; 04142015@45, 7/13/2015; 04172015@46, 7/16/2015; 04242015@27, 7/23/2015; 04292015@31, 7/28/2015; 04292015@81, 7/28/2015; 5082015@63, 8/6/2015; 04302015@9, 7/29/2015; 05112015@30, 8/9/2015; 5072015@14, 8/5/2015

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1699-2015

Related Recalls