D-804-2013 Class II Terminated
FDA drug recall D-804-2013 was initiated by Fresenius Kabi USA, LLC on Jun 24, 2013 and is designated Class II. Reason for recall: Subpotent Drug; 15-month stability test station The recall status is terminated (terminated Apr 7, 2015). Affected quantity: 221,600 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 24, 2013
- Initiation Date
- Jun 24, 2013
- Termination Date
- Apr 7, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 221,600 vials
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
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: 6003648, Exp. 6/2013
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-804-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026