Testosterone Enanthate Injection Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Testosterone Enanthate 200 mg/ml Injection due to FDA inspection findings of GMP violations that may impact sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a sterile injectable drug where sterility assurance is compromised due to GMP violations, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
The Compounding Pharmacy of America is recalling Testosterone Enanthate 200 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature. The recall involves 120 ml vials distributed nationwide between November 2014 and May 2015. Specific lot codes include 12022014@35, 01122015@40, 12312014@28, 03022015@71, 03122015@1, 04222015@2, and 04282015@48.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the product's quality and sterility, creating a lack of assurance that the medication is sterile.
Patients who have received this medication should contact their healthcare provider for guidance. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Testosterone Enanthate 200 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable Steroid
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- All lots distributed between November 2014 and May 2015
- 12022014@35
- 5/31/2015
- 01122015@40
- 7/11/2015
- 12312014@28
- 6/29/2015
- 03022015@71
- 8/29/2015
- 03122015@1
- 9/8/2015
- 04222015@2
- 10/19/2015
- 04282015@48
- 10/25/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 382 recalled by The Compounding Pharmacy of America under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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