FDA-Drug2015-09-23Class II

Morphine 45 mg/ml + Bupivacaine 8 mg/ml + Baclofen 25 mcg/ml 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
66 ml
Manufactured in
6216 Highland Place Way Ste 101-A, Knoxville, TN, United States
Products
Morphine 45 mg/ml + Bupivacaine 8 mg/ml + Baclofen 25 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1703-2015

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