Why it was recalled
cGMP Deviation
Product description
0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31
Lot numbers, UPCs & expiration codes
Lot: P380063 Exp. 12/2019
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-1190-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 6, 2018
- FDA report date
- Sep 26, 2018
- Quantity
- 5184 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-1190-2018, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 80976
- Address
- 1 Baxter Pkwy
- Code information
- Lot: P380063 Exp. 12/2019
- Postal code
- 60015-4625
- Report date
- Sep 26, 2018
- Product type
- Drugs
- Recall number
- D-1190-2018
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Product quantity
- 5184 bags
- Termination date
- Oct 1, 2020
- Reason for recall
- cGMP Deviation
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31
- Distribution pattern
- Nationwide.
- Recall initiation date
- Sep 6, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 15, 2018