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.
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: 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
- Category
- Drug — Compounded Injectable
- Affected units
- 1
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
Part of a larger recall action
This product is one of 130 recalled by Vita Pharmacy, LLC dba Talon Compounding Pharmacy 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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