FDA recall D-0866-2016

Product

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.

Reason for recall

Failed Impuities/Degradation Specifications

Distribution

Nationwide and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2016-05-04

Report date

2016-06-01

Termination date

2017-01-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Zurich, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0866-2016