Why it was recalled
Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
Product description
0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
Lot numbers, UPCs & expiration codes
Lot #: a) P309187, Exp 10/14; b) P298190, Exp 08/14
Where it was sold
Nationwide, Puerto Rico, Singapore, and Hong Kong
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-1591-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 11, 2014
- FDA report date
- Sep 24, 2014
- Quantity
- a) 217,536 bags; b) 161,760 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp.
Original FDA data
Every field from FDA enforcement report D-1591-2014, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 68728
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: a) P309187, Exp 10/14; b) P298190, Exp 08/14
- Postal code
- 60015-4625
- Report date
- Sep 24, 2014
- Product type
- Drugs
- Recall number
- D-1591-2014
- Classification
- Class I
- Recalling firm
- Baxter Healthcare Corp.
- Product quantity
- a) 217,536 bags; b) 161,760 bags
- Termination date
- Sep 21, 2016
- Reason for recall
- Presence of Particulate Matter: particulate matter identified as fibers and/or plastics.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container bags, NDC 0338-0049-41, Product Code 2B1306; and b) 100 mL VIAFLEX Container bags, NDC 0338-0049-18, Product Code 2B1302, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA.
- Distribution pattern
- Nationwide, Puerto Rico, Singapore, and Hong Kong
- Recall initiation date
- Jul 11, 2014
- Initial firm notification
- Letter
- Center classification date
- Sep 18, 2014