Why it was recalled
Lack of Assurance of Sterility; increased complaints received for leaks
Product description
0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , Product code 2B1308, NDC 0338-0049-31
Lot numbers, UPCs & expiration codes
Product code: 2B1308; Lot#: P316497, exp date: 10/2015
Where it was sold
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-0429-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 23, 2015
- FDA report date
- Apr 8, 2015
- Quantity
- 196,128 containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp
Original FDA data
Every field from FDA enforcement report D-0429-2015, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 70695
- Address
- 1 Baxter Pkwy
- Code information
- Product code: 2B1308; Lot#: P316497, exp date: 10/2015
- Postal code
- 60015-4625
- Report date
- Apr 8, 2015
- Product type
- Drugs
- Recall number
- D-0429-2015
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corp
- Product quantity
- 196,128 containers
- Termination date
- Oct 20, 2016
- Reason for recall
- Lack of Assurance of Sterility; increased complaints received for leaks
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi Pack, Rx Only, Baxter Healthcare Corporation, Deerfield, IL , Product code 2B1308, NDC 0338-0049-31
- Distribution pattern
- Nationwide and Singapore
- Recall initiation date
- Mar 23, 2015
- Initial firm notification
- Letter
- Center classification date
- Mar 31, 2015