FDA-Drug2015-09-23Class II
Hydromorphone 70 mg/ml +Fentanyl 16,000 mcg/ml + Bupivacaine 12 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 900 mcg/ml Intrathecal Solution, Sterile-Preservative Free, 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
22 ml
Manufactured in
6216 Highland Place Way Ste 101-A, Knoxville, TN, United States
Products
Hydromorphone 70 mg/ml +Fentanyl 16,000 mcg/ml + Bupivacaine 12 mg/ml + Clonidine 1,000 mcg/ml, Baclofen 900 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1681-2015Don't want to check this manually?
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