FDA-Drug2015-10-14Class II

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

Diabetes Corporation of America dba DCA Pharmacy
Hazard

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.

Sold states
KY, OH, TN
Affected count
129 vials
Manufactured in
233 Bedford Way, N/A, Franklin, TN, United States
Products
Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0006-2016

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