Estradiol Pellets Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Estradiol 18 mg sterile pellets due to 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 classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving potential sterility failures in sterile products are categorized as Severe (Score 4) due to the risk of infection.
Plain-English summary
The Compounding Pharmacy of America is recalling Estradiol 18 mg, Sterile Pellets. The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.
The affected product consists of 120 pellets per unit. The recall covers all lots distributed nationwide between November 2014 and May 2015. Specific lot codes and dates include 12112014@4, 02102015@18, 03022015@59, 03242015@96, and 04292015@16.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- Estradiol 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Sterile Pellets
- 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
- 12112014@4
- 6/9/2015
- 02102015@18
- 8/9/2015
- 03022015@59
- 8/29/2015
- 03242015@96
- 9/20/2015
- 04292015@16
- 10/26/2015
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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