Estradiol Pellets Recalled for Lack of Sterility Assurance
The Compounding Pharmacy of America is recalling Estradiol 25 mg sterile pellets nationwide 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 recall is classified as FDA Class II and involves a lack of sterility assurance for a sterile product, which poses a significant risk of infection or serious injury.
Plain-English summary
The Compounding Pharmacy of America, Inc. is recalling Estradiol 25 mg, Sterile Pellets. The recall involves 144 pellets per unit and was distributed nationwide. 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. Specific lot codes include 12012014@59, 01122015@34, 02102015@42, 03162015@12, 04282015@59, and 05052015@65. The agency classification for this recall is Class II.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Estradiol 25 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Sterile Pellets
- Affected units
- 144
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 (13)
- All lots distributed between November 2014 and May 2015
- 12012014@59
- 5/30/2015
- 01122015@34
- 7/11/2015
- 02102015@42
- 7/1/2015
- 03162015@12
- 9/12/2015
- 04282015@59
- 10/25/2015
- 05052015@65
- 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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