Hydromorphone 45 mg/ml + Fentanyl 10 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 45 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 15 mg/ml + Baclofen 720 mcg/ml Intrathecal Solution, Ster…

Recall number

D-1674-2015

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 45 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 15 mg/ml + Baclofen 720 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN