RecallRadar

FDA Drug recall D-0006-2016

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

On 2015-10-14 the FDA classified a Class II recall of Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Frank… by Diabetes, citing 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 ster….

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0006-2016
ClassificationClass II
Statusterminated
Initiated2015-09-23
Published2015-10-14
Last updated2026-09-13 11:51 UTC
CompanyDiabetes
DistributionKY, OH, TN

Product

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

Reason

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.

Identifiers

code_infoLot #: 101614, Exp 4/30/2015

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0006-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.