Morphine 50 mg/ml Solution, Sterile-Preservative Free, 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; 04142015@54, 6/13/2015; 04092015@68, 6/8/2015; 02252015@6, 5/26/2015; 05042015@68, 7/3/2015; 03022015@20, 05/31/2015; 031192015@5, 6/9/2015; 03092015@22, 6/7/2015; 03122015@3, 6/10/2015; 03162015@81, 6/14/2015; 03242015@74, 6/22/2015, 03302015@64, 6/28/2015; 04062015@46, 7/5/2015; 04212015@25, 6/20/2015; 04222015@18, 6/21/2015, 04242015@56, 6/23/2015; 04272015@29, 6/26/2015; 05012015@18, 6/30/2015; 05082015@32, 7/7/2015
  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:

Morphine 50 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Product Codes/Lot Numbers:

All lots distributed between November 2014 and May 2015; 04142015@54, 6/13/2015; 04092015@68, 6/8/2015; 02252015@6, 5/26/2015; 05042015@68, 7/3/2015; 03022015@20, 05/31/2015; 031192015@5, 6/9/2015; 03092015@22, 6/7/2015; 03122015@3, 6/10/2015; 03162015@81, 6/14/2015; 03242015@74, 6/22/2015, 03302015@64, 6/28/2015; 04062015@46, 7/5/2015; 04212015@25, 6/20/2015; 04222015@18, 6/21/2015, 04242015@56, 6/23/2015; 04272015@29, 6/26/2015; 05012015@18, 6/30/2015; 05082015@32, 7/7/2015

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1607-2015

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