Estradiol Valerate Injection Recall Due to Sterility Assurance Failure
Talon Compounding Pharmacy is recalling Estradiol Valerate 50mg/ml Injectable (Lot 09162021:22) distributed across the United States because the manufacturer cannot assure the product's 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: This is an FDA Class II recall of a sterile injectable drug product. Failure to assure sterility in injectable medications presents significant risk of infection and serious harm, meeting the threshold for Severe classification.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Estradiol Valerate 50mg/ml Injectable (Rx only) due to lack of assurance of sterility. The affected product was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
The recalled lot is Lot 09162021:22 with a Beyond Use Date of 03/15/2022. Patients who have received this medication should consult with their healthcare provider about whether they may have been affected and what steps to take.
The recalled product
- Product
- ESTRADIOL VALERATE 50MG/ML INJ #2 INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Manufacturer
- Vita Pharmacy, LLC dba Talon Compounding Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- sterility-failure
- infection-risk
- 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: 09162021:22 BUD: 03/15/2022
Distribution
Distribution scope not specified by the agency.
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