Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527
Reported: October 14, 2015 Initiated: September 23, 2015 #D-0006-2016
Product Description
Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527
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.
Details
- Recalling Firm
- Diabetes Corporation of America dba DCA Pharmacy
- Units Affected
- 129 vials
- Distribution
- KY, OH, TN
- Location
- Franklin, TN
Frequently Asked Questions
What product was recalled? ▼
Sermorelin 6mg/6mL Lyophilized Powder, Sterile Compound for Subcutaneous Injection, Diabetes Corporation of America dba DCA Pharmacy, Franklin, TN 37064-5527. Recalled by Diabetes Corporation of America dba DCA Pharmacy. Units affected: 129 vials.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 14, 2015. Severity: Moderate. Recall number: D-0006-2016.
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