Drug recall: Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj. 20 mg/mL Injection in vials, Rx only, Talon Compounding Pharmacy…

United States including Washington, D.C. and Puerto Rico

Vita Pharmacy, LLC dba Talon Compounding Pharmacy, San Antonio, TX.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

The table shows 60 of 130 product records. The FDA enforcement report lists all the records.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

Drug events that started in 2021

299

Share of these events in Class II

60%

Product records in this event

130

Events of the firm on the register

1

• FDA enforcement report D-0097-2022The FDA record of the first product of this event.
• FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
• FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Where was the product distributed?

The FDA record gives this distribution: United States including Washington, D.C. and Puerto Rico

What quantity of product is in FDA event 88862?

The event has 130 product records. The first record gives this quantity: 335 vials

How did the recall start?

The FDA record says: Voluntary: Firm initiated

How many drug recalls of 2021 have the same class?

60% of the 299 drug events that started in 2021 are in Class II.