Drug 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.
D-804-2013
Product summary
- Event
- Event 65512
- Status
- Terminated
- Classification
- Class II
- Quantity
- 221,600 vials
- Official record key
drug-enforcement:D-804-2013
Official wording
Reason: Subpotent Drug; 15-month stability test station
Code information: Lot #: 6003648, Exp. 6/2013
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Subpotent