Estradiol Valerate Injectable Recalled for Lack of Sterility Assurance
Talon Compounding Pharmacy is recalling Estradiol Valerate 10mg/mL Injectable due to lack of assurance of sterility. The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
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 recall is classified as FDA Class II. Injectable drugs lacking sterility assurance present a significant risk of serious harm including infection, sepsis, and other serious adverse effects. The broad distribution across the United States and the injectable route of administration elevate the potential impact.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Estradiol Valerate 10mg/mL in Ethyl Oleate 10mg/mL Injectable (Rx only) due to lack of assurance of sterility. The recalled product is identified as Lot 06232021:55 with a Beyond Use Date (BUD) of 12/20/2021.
The affected product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Patients who have received this medication should consult with their healthcare provider regarding appropriate follow-up care.
This is a Class II recall issued by the U.S. Food and Drug Administration. Consumers with questions or concerns about this recall should contact their pharmacist or healthcare provider.
The recalled product
- Product
- ESTRADIOL VALERATE 10MG/ML IN ETHYL OLEATE 10MG/ML INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected units
- 2
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: 06232021:55 BUD: 12/20/2021
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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