Compounded Testosterone and Estradiol Injection Recalled for Sterility Concerns
The Compounding Pharmacy of America is recalling Testosterone Bi-Blend and Estradiol Valerate injections due to FDA inspection findings regarding sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls involving potential sterility failures in injectable products are classified as Severe (Score 4) due to the risk of serious injury from non-sterile administration.
Plain-English summary
The Compounding Pharmacy of America is recalling Testosterone Bi-Blend 15 mg/ml + Estradiol Valerate 5 mg/ml Injection, Multi-Dose Vial. The product is sterile, room temperature, and available in 12 ml vials. The recall covers all lots distributed between November 2014 and May 2015, including lot 03252015@48. Distribution was nationwide.
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 product is sterile.
Consumers and healthcare providers who have this product should stop using it and contact the recalling firm or their healthcare provider for instructions on return or disposal.
The recalled product
- Product
- Testosterone Bi-Blend 15 mg/ml +Estradiol Valerate 5 mg/ml Injection, Multi-Dose Vial,Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Compounded Injectable
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 (2)
- All lots distributed between November 2014 and May 2015 03252015@48
- 9/21/15
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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