Sermorelin 6mg/ Lyophilized Powder recalled over sterility concerns

Recall date

September 23, 2015

Source

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

Official notice title

Diabetes Corporation of America dba DCA Pharmacy recalls Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba…

Recall number

D-0006-2016

FDA classification

Class II

Brand / firm

Diabetes Corporation of America dba DCA Pharmacy

Sold / distributed

KY, OH, TN

Why it was recalled

Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility assurance.

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

What was recalled

Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527