The Compounding Pharmacy of America recalls Morphine 50 mg/ml + Fentanyl 2,000 mcg/ml + Bupivacaine 10 mg/ml Clonidine 200 mcg/ml, Solution, Sterile, Preservative F
Recalled September 23, 2015 · FDA recall D-1708-2015 · The Compounding Pharmacy of America
Hazard
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility · FDA Class II
Units
86 ml
Sold at
Nationwide
Description
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Product
Morphine 50 mg/ml + Fentanyl 2,000 mcg/ml + Bupivacaine 10 mg/ml Clonidine 200 mcg/ml, Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer(s)
The Compounding Pharmacy of America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →