FDA Recalls Testosterone and Estradiol Injectable Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Testosterone Bi-Blend and Estradiol Valerate injectable due to FDA inspection findings of GMP violations impacting sterility.
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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable medication, which poses a risk of serious infection or adverse health consequences.
Plain-English summary
The Compounding Pharmacy of America is recalling Testosterone Bi-Blend 50 mg/ml + Estradiol Valerate 2.5 mg/ml Injectable, 12 ml vials. The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility.
The recall covers all lots distributed between November 2014 and May 2015. The product was distributed nationwide. The specific lot codes identified in the recall notice are 03252015@48 and 9/21/2015.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Testosterone Bi-Blend 50 mg/ml + Estradiol Valerate 2.5 mg/ml Injectable, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable
- 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 (3)
- All lots distributed between November 2014 and May 2015
- 03252015@48
- 9/21/2015
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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