Why it was recalled
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
Product description
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
Lot numbers, UPCs & expiration codes
Lot# 52-031-JT, Exp 10/16
Where it was sold
US: Nationwide and Singapore
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0831-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 8, 2016
- FDA report date
- Apr 27, 2016
- Quantity
- 22292 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0831-2016, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 73472
- Address
- 275 N Field Dr
- Code information
- Lot# 52-031-JT, Exp 10/16
- Postal code
- 60045-2579
- Report date
- Apr 27, 2016
- Product type
- Drugs
- Recall number
- D-0831-2016
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 22292 bags
- Termination date
- Dec 6, 2017
- Reason for recall
- Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- US: Nationwide and Singapore
- Recall initiation date
- Mar 8, 2016
- Initial firm notification
- Letter
- Center classification date
- Apr 21, 2016