Estradiol Pellets Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Estradiol 20 mg sterile pellets nationwide because FDA inspections identified GMP violations that may impact 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 agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility for a sterile injectable product, which aligns with the 'Severe' criteria for significant potential injury risks.
Plain-English summary
The Compounding Pharmacy of America is recalling Estradiol 20 mg, Sterile Pellets. The recall covers 120-pellet units distributed nationwide between November 2014 and May 2015. Specific lot codes and dates are listed in the official recall notice.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the quality and sterility of the product, meaning there is a lack of assurance that the pellets are sterile.
Consumers who have purchased these pellets should stop using them and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- Estradiol 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Hazard
- Affected units
- 120
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 (11)
- All lots distributed between November 2014 and May 2015
- 12082014@58
- 6/6/2015
- 02032015@42
- 7/1/2015
- 02272015@28
- 8/26/2015
- 03242015@97
- 9/20/2015
- 05052015@62
- 11/1/2015
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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