Fresenius Kabi USA, LLC recalls OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius…

Recall date

May 4, 2016

Source

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

Recall number

D-0866-2016

FDA classification

Class II

Brand / firm

Fresenius Kabi USA, LLC

Sold / distributed

Nationwide and Puerto Rico.

Why it was recalled

Failed Impuities/Degradation Specifications

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

What was recalled

OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.