Fentanyl Citrate 1 recalled over sterility concerns

Recall date

February 4, 2016

Source

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

Official notice title

Hartley Medical Center Pharmacy, Incorporated recalls Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/ Clonidine HCL 450 mcg/ml, vol. 40 ml syringe…

Recall number

D-0755-2016

FDA classification

Class II

Brand / firm

Hartley Medical Center Pharmacy, Incorporated

Sold / distributed

Nationwide. No foreign distribution.

Why it was recalled

Lack of Assurance of 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

Fentanyl Citrate 1.275 mg/ml/Baclofen 150 mcg/ml/Bupivacaine HCL 20 mg/ml/ Clonidine HCL 450 mcg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA