Drug product
Norepinephrine 8 mg (32 mcg/mL) added to 0.9% Sodium Chloride Injection 250 mL Bag, Rx only, Compounded by: QuVA Pharma 1075 West Park One Drive Suite 100 Sugar Land, TX 77478. Product Code 70092-9035-05
D-0295-2019
Product summary
- Event
- Event 81644
- Status
- Terminated
- Classification
- Class III
- Quantity
- 168 bags
- Official record key
drug-enforcement:D-0295-2019
Official wording
Reason: Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Code information: Lot #:10016014 Exp. 01/06/2019
Distribution pattern: CA only
Derived failure modes
-
Unknown
Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride