D-0006-2016 Class II Terminated
FDA drug recall D-0006-2016 was initiated by Diabetes Corporation of America dba DCA Pharmacy on September 23, 2015 and is designated Class II. 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. The recall status is terminated (terminated January 12, 2016). Affected quantity: 129 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- October 14, 2015
- Initiation Date
- September 23, 2015
- Termination Date
- January 12, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 129 vials
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.
Distribution Pattern
KY, OH, TN
Code Information
Lot #: 101614, Exp 4/30/2015