Estradiol Valerate Injectable Injection Lacks Sterility Assurance
Talon Compounding Pharmacy is recalling Estradiol Valerate 50 mg/mL injectable due to lack of assurance of sterility. The affected product is a prescription injection distributed across the United States, Puerto Rico, and Washington, D.C.
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. Lack of sterility assurance in injectable medications presents a serious risk of infection or sepsis, which can result in hospitalization or serious injury. Class II recalls with this type of hazard profile meet the "Severe" threshold.
Plain-English summary
Talon Compounding Pharmacy (Vita Pharmacy, LLC) is recalling Estradiol Valerate 50 mg/mL in Ethyl Oleate Injectable due to lack of assurance of sterility. The product is a prescription-only injectable medication.
The affected product includes two lots: Lot 09162021:29 with Beyond-Use Date (BUD) of 03/15/2022, and Lot 09132021:31 with BUD of 03/12/2022. A total of 15 vials were distributed. The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico.
Patients currently using this product should consult their healthcare provider or pharmacist regarding continued use and appropriate next steps. Healthcare providers and patients should report any adverse events to the FDA MedWatch program or contact Talon Compounding Pharmacy directly.
The recalled product
- Product
- ESTRADIOL VALERATE 50MG/ML IN ETHYL OLEATE INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Category
- Drug — Injectable / Compounded
- Affected units
- 15
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 (2)
- Lot: 09162021:29 BUD: 03/15/2022
- 09132021:31 BUD: 03/12/2022
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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