Estradiol Pellets Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Estradiol 6 mg sterile pellets nationwide because FDA inspections found 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. 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 serious infection, even without reported hospitalizations in the text.
Plain-English summary
The Compounding Pharmacy of America, Inc. is recalling Estradiol 6 mg, Sterile Pellets. The recall covers 144 pellets distributed nationwide between November 2014 and May 2015. Specific lot codes include 11212014@13, 12182014@35, 02202015@1, 03022015@48, 03172015@33, and 04232015@24.
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 agency has classified this as a Class II recall, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
Consumers who have these products should stop using them and contact their healthcare provider or the recalling firm for instructions on return or disposal. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- Estradiol 6 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
- 11212014@13
- 5/20/2015
- 12182014@35
- 6/16/2015
- 02202015@1
- 8/19/2015
- 03022015@48
- 8/29/2015
- 03172015@33
- 9/13/2015
- 04232015@24
- 10/20/2015
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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