Class II
Terminated
Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527
- Recall Initiated
- September 23, 2015
- Posted
- October 14, 2015
- Recall Number
- D-0006-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 129 vials
- Firm Location
- Franklin, TN, United States
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
Lot / Code Info
Lot #: 101614, Exp 4/30/2015
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