Sermorelin Lyophilized Powder (DCA Pharmacy) – Sterility Risk (2015)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527
Brand
Diabetes Corporation of America dba DCA Pharmacy
Lot Codes / Batch Numbers
Lot #: 101614, Exp 4/30/2015
Products Sold
Lot #: 101614, Exp 4/30/2015
Diabetes Corporation of America dba DCA Pharmacy is recalling Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corpora due to Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization whi. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
KY, OH, TN
Page updated: Jan 7, 2026