Drug product
Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-7715-02, Barcode (01) 0 030409 771502 2
D-0831-2016
Product summary
- Firm
- Hospira Inc.
- Event
- Event 73472
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22292 bags
- Official record key
drug-enforcement:D-0831-2016
Official wording
Reason: Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Code information: Lot# 52-031-JT, Exp 10/16
Distribution pattern: US: Nationwide and Singapore
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination