Drug product
Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC 0409-3375-04
D-0898-2017
Product summary
- Event
- Event 77288
- Status
- Terminated
- Classification
- Class II
- Quantity
- (720503A): 43,200 vials, (720603A): 400 vials
- Official record key
drug-enforcement:D-0898-2017
Official wording
Reason: GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Code information: 720503A, 720603A (Canada only)
Distribution pattern: Nationwide, Canada and Singapore
Derived failure modes
-
Manufacturing or process control
GMP Deviation