FDAJune 2, 2015drug

Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Clonidine 1,300 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

What to do

FDA enforcement status: Terminated

Brands named

compounding pharmacycompounding

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Clonidine 1,300 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN — Recall Details · AllClear