Why it was recalled
Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
Product description
0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02
Lot numbers, UPCs & expiration codes
Lot # C980227; Exp. 11/16
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-0957-2016
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 15, 2015
- FDA report date
- Jun 15, 2016
- Quantity
- 255,852 VIAFLEX Plastic Containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp.
Original FDA data
Every field from FDA enforcement report D-0957-2016, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 72816
- Address
- 1 Baxter Pkwy
- Code information
- Lot # C980227; Exp. 11/16
- Postal code
- 60015-4625
- Report date
- Jun 15, 2016
- Product type
- Drugs
- Recall number
- D-0957-2016
- Classification
- Class I
- Recalling firm
- Baxter Healthcare Corp.
- Product quantity
- 255,852 VIAFLEX Plastic Containers
- Termination date
- Apr 15, 2022
- Reason for recall
- Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container Bag, Rx Only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-0049-02
- Distribution pattern
- Nationwide
- Recall initiation date
- Dec 15, 2015
- Initial firm notification
- Letter
- Center classification date
- Jun 6, 2016