Hydromorphone 60 mg/ml + Fentanyl 20 recalled over sterility concerns

Recall date

June 2, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

The Compounding Pharmacy of America recalls Hydromorphone 60 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,000 mcg/ml + Baclofen 300 mcg/ml I…

Recall number

D-1677-2015

FDA classification

Class II

Brand / firm

The Compounding Pharmacy of America

Sold / distributed

Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Hydromorphone 60 mg/ml + Fentanyl 20,000 mcg/ml + Bupivacaine 40 mg/ml + Clonidine 1,000 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN