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Injectable Hormone Recalled

July 13, 2017

Apothecary By Design is pulling 25 10-mL multidose vials of progesterone injection in olive oil with benzyl alcohol 10%, 50 mg/mL, according to the July 5, 2017, US Food and Drug Administration (FDA) Enforcement Report.

“The metal container closure adheres to the rubber stopper on some of the units of the batch, which can impact the integrity of the container closure,” the FDA explained.

The 25 recalled vials are from lot 04192017@1, which has an expiration date of September 30, 2017. They were distributed across the United States.

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Apothecary By Design initiated the voluntary recall June 5, 2017. It was categorized class II by the FDA June 28, 2017, indicating exposure to the affected product could cause temporary or medically reversible adverse health consequences but that the likelihood of serious effects is remote.

Progesterone injection is a female hormone medication for women who do not naturally make enough progesterone.

Jolynn Tumolo

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