Tri-Mix (30/1/10) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    All lots distributed between November 2014 and May 2015; 01302015@29, 7/29/2015; 04162015@31, 10/13/2015, 12162014@27, 6/14/2015; 01192015@8, 7/18/2015; 01142015@29, 7/13/2015; 01262015@49, 7/25/2015; 01092015@32, 7/8/2015; 01292015@37, 7/28/2015, 02112015@30, 8/10/2015; 02262015@5, 8/25/2015; 02272015@73, 8/26/2015; 03032015@18, 8/30/2015; 03062015@32, 9/2/2015; 03192015@44, 9/15/2015; 03302015@15, 9/26/2015; 04082015@8, 10/5/2015; 04062015@49, 10/3/2015; 04222015@81, 10/19/2015; 04302015@36, 10/27/2015; 05052015@41, 11/1/2015
  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:

Tri-Mix (30/1/10) Injectable, The Compounding Pharmacy of America, Knoxville, TN

Product Codes/Lot Numbers:

All lots distributed between November 2014 and May 2015; 01302015@29, 7/29/2015; 04162015@31, 10/13/2015, 12162014@27, 6/14/2015; 01192015@8, 7/18/2015; 01142015@29, 7/13/2015; 01262015@49, 7/25/2015; 01092015@32, 7/8/2015; 01292015@37, 7/28/2015, 02112015@30, 8/10/2015; 02262015@5, 8/25/2015; 02272015@73, 8/26/2015; 03032015@18, 8/30/2015; 03062015@32, 9/2/2015; 03192015@44, 9/15/2015; 03302015@15, 9/26/2015; 04082015@8, 10/5/2015; 04062015@49, 10/3/2015; 04222015@81, 10/19/2015; 04302015@36, 10/27/2015; 05052015@41, 11/1/2015

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1776-2015

Related Recalls