FDA-Drug2016-06-01Class II

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 63323-365-04

Fresenius Kabi USA, LLC
Hazard

Failed Impuities/Degradation Specifications

Sold states
Nationwide and Puerto Rico.
Affected count
40,280 vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
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 63323-365-04

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0867-2016

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