Estradiol Pellets Recalled for Lack of Sterility Assurance
The Compounding Pharmacy of America is recalling Estradiol 10 mg Sterile Pellets nationwide 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. Per the rubric, FDA Class II recalls involving significant quality/sterility issues that could lead to serious injury are classified as Severe.
Plain-English summary
The Compounding Pharmacy of America is recalling Estradiol 10 mg Sterile Pellets. The recall covers 212 pellets distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the recall documentation.
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, resulting in a lack of assurance of sterility.
Consumers who have purchased these specific lots of Estradiol 10 mg Sterile Pellets should stop using them and contact their healthcare provider or the recalling firm for instructions on how to return the product.
The recalled product
- Product
- Estradiol 10 mg Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Hazard
- Affected units
- 212
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 (17)
- All lots distributed between November 2014 and May 2015
- 12082014@56
- 6/6/2015
- 01222015@28
- 7/21/2015
- 01062015@73
- 7/5/2015
- 03022015@55
- 8/29/2015
- 03242015@94
- 9/20/2015
- 04222015@32
- 10/19/2015
- 04222015@47
- 04222015@49
- 04302015@54
- 10/27/2015
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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