Drug & medication recalls Moderate risk

Estradiol 100 mg recalled over sterility concerns

Recall date
June 2, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
The Compounding Pharmacy of America recalls Estradiol 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
Recall number
D-1465-2015
FDA classification
Class II
Brand / firm
The Compounding Pharmacy of America
Sold / distributed
Nationwide

Why it was recalled

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

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

What was recalled

Estradiol 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN

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