17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection recalled over sterility concerns

Recall date

September 3, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma recalls 17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625…

Recall number

D-299-2016

FDA classification

Class II

Brand / firm

Kalman Health & Wellness, Inc. dba Essential Wellness Pharma

Sold / distributed

Nationwide

Why it was recalled

Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection, 5 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.