Drug product
Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417.
D-0003-2019
Product summary
- Event
- Event 80980
- Status
- Terminated
- Classification
- Class I
- Quantity
- 528 bags
- Official record key
drug-enforcement:D-0003-2019
Official wording
Reason: Subpotent Drug: Product may not have the active ingredient present in the bag.
Code information: Lot #:30000271, Exp 10/1/18
Distribution pattern: Nationwide to hospitals in USA
Derived failure modes
-
Potency or specification failure
Subpotent