Why it was recalled
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Product description
0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03
Lot numbers, UPCs & expiration codes
Lot #: C929844, Exp 5/31/2015; C926873, Exp 4/30/2015; C928630, Exp 4/30/2015.
Where it was sold
Nationwide
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-0425-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 18, 2015
- FDA report date
- Apr 1, 2015
- Quantity
- 597,498 units total
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp.
Original FDA data
Every field from FDA enforcement report D-0425-2015, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 70770
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: C929844, Exp 5/31/2015; C926873, Exp 4/30/2015; C928630, Exp 4/30/2015.
- Postal code
- 60015-4625
- Report date
- Apr 1, 2015
- Product type
- Drugs
- Recall number
- D-0425-2015
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corp.
- Product quantity
- 597,498 units total
- Termination date
- Feb 24, 2016
- Reason for recall
- Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0049-03
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 18, 2015
- Initial firm notification
- Letter
- Center classification date
- Mar 25, 2015