Estradiol Valerate Injectable Recalled for Lack of Sterility Assurance
Talon Compounding Pharmacy is recalling Estradiol Valerate 40mg/mL injectable across the United States due to lack of assurance of sterility. The affected product was distributed in 11 vials with multiple lot numbers.
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: The FDA classified this as a Class II recall. Lack of sterility assurance in an injectable pharmaceutical product represents a significant risk of serious adverse health consequences, including infection or sepsis, which can require hospitalization. Although no illnesses are reported in the source text, the inherent hazard of a non-sterile injectable product administered directly into the body meets the threshold for Severe classification.
Plain-English summary
Vita Pharmacy, LLC dba Talon Compounding Pharmacy is recalling Estradiol Valerate 40mg/mL in Ethyl Oleate Injectable (Rx only) due to lack of assurance of sterility. The product was manufactured and distributed from Talon Compounding Pharmacy located at 2950 Thousand Oaks Drive Suite 25, San Antonio, Texas 78247.
A total of 11 vials were affected. The recalled product includes the following lots with their corresponding Beyond Use Dates (BUD): Lot 09082021:11 (BUD 03/07/2022), Lot 07022021:66 (BUD 12/29/2021), Lot 05202021:46 (BUD 11/16/2021), and Lot 08192021:24 (BUD 02/15/2022).
The product was distributed throughout the United States, including Washington, D.C. and Puerto Rico. Patients who have received this product should contact their healthcare provider. Healthcare professionals should not dispense or administer any remaining product from the affected lots and should contact the recalling firm or the FDA with questions.
The recalled product
- Product
- ESTRADIOL VALERATE 40MG/ML IN ETHYL OLEATE INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Affected units
- 11
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: 09082021:11 BUD: 03/07/2022
- 07022021:66 BUD: 12/29/2021
- 05202021:46 BUD: 11/16/2021
- 08192021:24 BUD: 02/15/2022
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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