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.

FDA recall notice · announced July 24, 2013 · Fresenius Kabi

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Reason for recall

Subpotent Drug; 15-month stability test station

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot #: 6003648, Exp. 6/2013
Quantity: 221,600 vials
Status: Terminated
Products in this recall event:
- 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. (D-804-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.