FDA-Drug2013-07-24Class II

Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.

Fresenius Kabi USA, LLC
Hazard

Subpotent Drug; 15-month stability test station

Sold states
Nationwide and Puerto Rico
Affected count
221,600 vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1 mL, APP Pharmaceuticals, LLC Schaumburg, IL, 60173, NDC 63323-012-01.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-804-2013

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