Estradiol Cypionate Injectable Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Estradiol Cypionate 5mg/ml injectable vials because FDA inspections identified GMP violations that may impact product 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 source text identifies the recall as FDA Class II. According to the severity rubric, an FDA Class II recall involving a sterile injectable product with GMP violations impacting sterility is classified as Severe (Score 4), as it carries a risk of significant injury or infection, even if specific hospitalization reports are not detailed in the provided text.
Plain-English summary
The Compounding Pharmacy of America is recalling Estradiol Cypionate 5mg/ml Injectable, ml Multi-Dose Vial, Sterile Room Temperature. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.
The affected product is a 32 ml total volume multi-dose vial. The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes and dates include 03122015@48 (9/8/2015), 04212015@20 (10/18/2015), and 05052015@37 (11/1/2015). The product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Estradiol Cypionate 5mg/ml Injectable, ml Multi-Dose Vial, Sterile Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable Sterile
- Hazard
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 (7)
- All lots distributed between November 2014 and May 2015
- 03122015@48
- 9/8/2015
- 04212015@20
- 10/18/2015
- 05052015@37
- 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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