FDAFDA · Food and drugs·Recall number D-0006-2016
Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527
Published October 14, 2015 · Recall initiated: September 23, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Diabetes Corporation of America dba DCA Pharmacy
- Distributor
- KY, OH, TN
- Lot
- Lot #: 101614, Exp 4/30/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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