FDA-Drug2015-09-23Class II
MYO-DEN (30 ml) 25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
The Compounding Pharmacy of America
Hazard
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Sold states
Nationwide
Affected count
218 ml
Manufactured in
6216 Highland Place Way Ste 101-A, Knoxville, TN, United States
Products
MYO-DEN (30 ml) 25 mg/ml Injection, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1739-2015Don't want to check this manually?
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