Estradiol Valerate Injectable Recalled Due to Lack of Sterility Assurance
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Estradiol Valerate 5mg/mL injectable across the United States, Washington D.C., and Puerto Rico due to lack of assurance of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable drug product with a defect affecting sterility assurance. Although no illnesses or injuries are reported in the source text, a lack of sterility assurance for injectable products creates a risk of serious harm (infection, sepsis) and meets the "risk-of-harm products where injury has not yet been reported" criterion for a High severity score.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Estradiol Valerate 5mg/mL in Ethyl Oleate 5mg/mL Injectable across the United States, including Washington D.C. and Puerto Rico. The recall affects seven vials with multiple lot numbers and expiration dates.
The product is being recalled due to lack of assurance of sterility. Patients who have received this injectable product should consult their healthcare provider regarding their treatment.
Affected lots include: 07232021:10 (BUD 01/19/2022), 04162021:56 (BUD 10/13/2021), 08172021:62 (BUD 02/13/2022), and 05272021:21 (BUD 11/23/2021). The product is a prescription injectable distributed by Talon Compounding Pharmacy in San Antonio, Texas.
The recalled product
- Product
- ESTRADIOL VALERATE 5MG/ML IN ETHYL OLEATE 5MG/ML 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
- lack-of-sterility
- 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 (4)
- Lot: 07232021:10 BUD: 01/19/2022
- 04162021:56 BUD: 10/13/2021
- 08172021:62 BUD: 02/13/2022
- 05272021:21 BUD: 11/23/2021
Distribution
Distribution scope not specified by the agency.
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