Hartley Medical Center Pharmacy product 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 Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr P…

Recall number

D-0765-2016

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

Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA