Recalls / Class II
Class IID-0831-2016
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
- Affected lot / code info
- Lot# 52-031-JT, Exp 10/16
Why it was recalled
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, N/A, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 22292 bags
- Distribution pattern
- US: Nationwide and Singapore
Timeline
- Recall initiated
- 2016-03-08
- FDA classified
- 2016-04-21
- Posted by FDA
- 2016-04-27
- Terminated
- 2017-12-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0831-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.