The Recall Desk
SevereFDA (Drugs)·D-0097-2022·Announced 2021-11-17

Estradiol Valerate Injection Recalled Due to Sterility Assurance Failure

Talon Compounding Pharmacy is recalling Estradiol Valerate 20 mg/mL injection vials distributed across the United States, Puerto Rico, and Washington D.C. due to lack of assurance of sterility.

What this means for you

Illness, injury, or structural failure has been reported. 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 poses significant risk of infection and potential serious injury or hospitalization; therefore this meets the criteria for a Severe (Score 4) recall.

Plain-English summary

Vita Pharmacy, LLC, doing business as Talon Compounding Pharmacy, is recalling Estradiol Valerate 20 mg/mL in Ethyl Oleate Injection in vials because the firm cannot assure that the product meets sterility requirements. A total of 335 vials have been distributed.

The recalled product was distributed throughout the United States, including Puerto Rico and Washington, D.C. Affected lot numbers include 04122021:51, 04232021:94, 05032021:52, 05242021:73, 05172021:47, 06302021:93, 06222021:98, 06072021:83, 07152021:86, 07222021:52, 08062021:11, 08192021:73, 08312021:22, 09162021:58, and 09082021:15, with Beyond Use Dates (BUDs) ranging from October 2021 to March 2022.

Patients or healthcare providers who have received this product should contact Talon Compounding Pharmacy at 2950 Thousand Oaks Drive, Suite 25, San Antonio, Texas 78247 for guidance. Patients should consult with their healthcare provider before discontinuing use.

The recalled product

Product
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
Manufacturer
Vita Pharmacy, LLC dba Talon Compounding Pharmacy
Category
Drug — Injectable / Compounded
Hazard
  • sterility-failure
  • infection-risk

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 (15)

  • 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

Distribution

Distribution scope not specified by the agency.

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