Status
Terminated
Drug Enforcement D-804-2013
Subpotent Drug; 15-month stability test station
Classification
Class II
Report Date
July 24, 2013
Termination Date
April 7, 2015
Product Information
- 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.
- Product quantity
- 221,600 vials
- Reason for recall
- Subpotent Drug; 15-month stability test station
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Fresenius Kabi USA, LLC
- Address
-
3 Corporate Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-804-2013
- Event ID
- 65512
- Recall initiation date
- June 24, 2013
- Center classification date
- July 17, 2013
- Code info
- Lot #: 6003648, Exp. 6/2013
- More code info
- —