FDA recall D-0006-2016

Product

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

Reason for recall

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.

Distribution

KY, OH, TN

Key facts

Status

Terminated

Initiation date

2015-09-23

Report date

2015-10-14

Termination date

2016-01-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Franklin, TN, United States

Primary source

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