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
Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product code 6E2323, NDC 0338-6307-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
Lot numbers, UPCs & expiration codes
Lot #: a) C847749, Exp 11/12; C847897, Exp 12/12; C860668, Exp 04/13; b) C855445, Exp 09/13; C861492, Exp 12/13
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-1690-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 21, 2012
- FDA report date
- Oct 3, 2012
- Quantity
- 55,664 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp.
Original FDA data
Every field from FDA enforcement report D-1690-2012, 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 #: a) C847749, Exp 11/12; C847897, Exp 12/12; C860668, Exp 04/13; b) C855445, Exp 09/13; C861492, Exp 12/13
- Postal code
- 60073-9799
- Report date
- Oct 3, 2012
- Product type
- Drugs
- Recall number
- D-1690-2012
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corp.
- Product quantity
- 55,664 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
- Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product code 6E2323, NDC 0338-6307-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Sep 21, 2012
- Initial firm notification
- Letter
- Center classification date
- Sep 25, 2012