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.
Reported: July 24, 2013 Initiated: June 24, 2013 #D-804-2013
Product Description
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
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 221,600 vials
- Distribution
- Nationwide and Puerto Rico
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Fresenius Kabi USA, LLC. Units affected: 221,600 vials.
Why was this product recalled? ▼
Subpotent Drug; 15-month stability test station
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 24, 2013. Severity: Moderate. Recall number: D-804-2013.
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