Why it was recalled
Lack of assurance of sterility
Product description
Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
Lot numbers, UPCs & expiration codes
Lot: 04122021:51 BUD: 10/09/2021; 04232021:94 BUD: 10/20/2021; 05032021:52 BUD: 10/30/2021; 05242021:73 BUD: 11/20/2021; 05172021:47 BUD: 11/13/2021; 06302021:93 BUD: 12/27/2021; 06222021:98 BUD: 12/19/2021; 06072021:83 BUD: 12/04/2021; 07152021:86 BUD: 01/11/2022; 07222021:52 BUD: 01/18/2022; 08062021:11 BUD: 02/02/2022; 08192021:73 BUD: 02/15/2022; 08312021:22 BUD: 02/27/2022; 09162021:58 03/15/2022; 09082021:15 BUD: 03/07/2022
Where it was sold
United States including Washington, D.C. and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0097-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 12, 2021
- FDA report date
- Nov 17, 2021
- Quantity
- 335 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Original FDA data
Every field from FDA enforcement report D-0097-2022, exactly as published.
Show all FDA fields
- City
- San Antonio
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 88862
- Address
- 2950 Thousand Oaks Dr Ste 25
- Code information
- Lot: 04122021:51 BUD: 10/09/2021; 04232021:94 BUD: 10/20/2021; 05032021:52 BUD: 10/30/2021; 05242021:73 BUD: 11/20/2021; 05172021:47 BUD: 11/13/2021; 06302021:93 BUD: 12/27/2021; 06222021:98 BUD: 12/19/2021; 06072021:83 BUD: 12/04/2021; 07152021:86 BUD: 01/11/2022; 07222021:52 BUD: 01/18/2022; 08062021:11 BUD: 02/02/2022; 08192021:73 BUD: 02/15/2022; 08312021:22 BUD: 02/27/2022; 09162021:58 03/15/2022; 09082021:15 BUD: 03/07/2022
- Postal code
- 78247-3347
- Report date
- Nov 17, 2021
- Product type
- Drugs
- Recall number
- D-0097-2022
- Classification
- Class II
- Recalling firm
- Vita Pharmacy, LLC dba Talon Compounding Pharmacy
- Product quantity
- 335 vials
- Termination date
- Oct 4, 2023
- Reason for recall
- Lack of assurance of sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive Ste 25, San Antonio, Texas 78247
- Distribution pattern
- United States including Washington, D.C. and Puerto Rico
- Recall initiation date
- Oct 12, 2021
- Initial firm notification
- Telephone
- Center classification date
- Nov 8, 2021