Estradiol Valerate Injectable Recalled for Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Estradiol Valerate 30 mg/mL Injectable due to lack of assurance of sterility. The product was distributed across the United States, Washington, D.C., and Puerto Rico.
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 FDA classified this as a Class II recall for a sterility assurance failure in an injectable drug product. Non-sterile injections pose a significant risk of serious infection and hospitalizations; this meets the Severe criterion for FDA Class II with significant injury risk.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Estradiol Valerate 30 mg/mL Injectable in ethyl oleate oil because the firm cannot assure that the product meets sterility requirements. The recalled product is a compounded injectable medication identified by Lot 04262021:43 with a Beyond Use Date of 10/23/2021.
This product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Consumers or healthcare providers who have received this product should contact their healthcare provider or pharmacist for guidance on whether they have received the affected lot.
The recalled product
- Product
- ESTRADIOL VALERATE 30MG/ML INJ #1 IN ETHYL OLEATE OIL INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Manufacturer
- Vita Pharmacy, LLC dba Talon Compounding Pharmacy
- Hazard
- sterility-failure
- injectable-contamination
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 (1)
- Lot: 04262021:43 BUD: 10/23/2021
Distribution
Distribution scope not specified by the agency.
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