Estradiol Valerate Injectable Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Estradiol Valerate 40 mg/ml injectable vials because FDA inspections found GMP violations that may impact sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the hazard involves a lack of assurance of sterility in an injectable drug, which carries a risk of significant injury or hospitalization if contaminated.
Plain-English summary
The Compounding Pharmacy of America is recalling Estradiol Valerate 40 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature. The product is distributed nationwide and consists of 36 ml total volume vials. The recall covers all lots distributed between November 2014 and May 2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The specific hazard is a lack of assurance of sterility.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for instructions on return or replacement.
The recalled product
- Product
- Estradiol Valerate 40 mg/ml Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable
- 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 (3)
- All lots distributed between November 2014 and May 2015
- 04302015@35
- 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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