Drug product
Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527
D-0006-2016
Product summary
- Event
- Event 72271
- Status
- Terminated
- Classification
- Class II
- Quantity
- 129 vials
- Official record key
drug-enforcement:D-0006-2016
Official wording
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.
Code information: Lot #: 101614, Exp 4/30/2015
Distribution pattern: KY, OH, TN
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility