Recalls / Class II
Class IID-804-2013
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.
- Affected lot / code info
- Lot #: 6003648, Exp. 6/2013
Why it was recalled
Subpotent Drug; 15-month stability test station
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, N/A, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 221,600 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-06-24
- FDA classified
- 2013-07-17
- Posted by FDA
- 2013-07-24
- Terminated
- 2015-04-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-804-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.