FDAClass IIOctober 14, 2015

Sermorelin 6mg/6mL Lyophilized Powder recall: Sterility Concern

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

Why was Sermorelin 6mg/6mL Lyophilized Powder 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 101614, Exp 4/30/2015

Product
Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN…
Recalling firm
Diabetes Corporation of America dba DCA Pharmacy
Quantity
129 vials
Distribution
KY, OH, TN
Recall date
October 14, 2015
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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