🔍 RecallPedia

HCG 1,000 IU/ml + Methylcobalamin 0.5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, 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; 04172015@3, 6/16/2015; 03242015@49, 5/23/2015; 03272015@31, 5/26/2015; 05052015@51, 7/4/2015; 03252015@2, 5/24/2015; 03252015@30, 5/24/2015; 03302015@45, 5/29/2015; 04162015@26, 6/15/2015; 04212015@7, 6/20/2015; 04172015@71, 6/16/2015; 04292015@53, 6/28/2015; 04072015@53, 6/6/2015; 04272015@44, 6/26/2015
  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:

HCG 1,000 IU/ml + Methylcobalamin 0.5 mg/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN

Product Codes/Lot Numbers:

All lots distributed between November 2014 and May 2015; 04172015@3, 6/16/2015; 03242015@49, 5/23/2015; 03272015@31, 5/26/2015; 05052015@51, 7/4/2015; 03252015@2, 5/24/2015; 03252015@30, 5/24/2015; 03302015@45, 5/29/2015; 04162015@26, 6/15/2015; 04212015@7, 6/20/2015; 04172015@71, 6/16/2015; 04292015@53, 6/28/2015; 04072015@53, 6/6/2015; 04272015@44, 6/26/2015

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1506-2015

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