Why it was recalled
Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
Product description
5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0173, NDC 0338-6308-03
Lot numbers, UPCs & expiration codes
Lot #: C828814, Exp 12/12; C841551, Exp 04/13
Where it was sold
Nationwide and Puerto Rico
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-1688-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 21, 2012
- FDA report date
- Oct 3, 2012
- Quantity
- 5,064 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp.
Original FDA data
Every field from FDA enforcement report D-1688-2012, exactly as published.
Show all FDA fields
- City
- Round Lake
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 63189
- Address
- Route 120 And Wilson Rd
- Code information
- Lot #: C828814, Exp 12/12; C841551, Exp 04/13
- Postal code
- 60073-9799
- Report date
- Oct 3, 2012
- Product type
- Drugs
- Recall number
- D-1688-2012
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corp.
- Product quantity
- 5,064 containers
- Termination date
- May 4, 2015
- Reason for recall
- Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0173, NDC 0338-6308-03
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Sep 21, 2012
- Initial firm notification
- Letter
- Center classification date
- Sep 25, 2012