Why it was recalled
Lack of Assurance of Sterility: Bags have potential to leak.
Product description
0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.
Lot numbers, UPCs & expiration codes
Lot #s: P389684; P389742, Exp. 8/31/2020
Where it was sold
Nationwide in the United States and Puerto Rico.
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-1514-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 18, 2019
- FDA report date
- Jul 31, 2019
- Quantity
- 139,680 Containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-1514-2019, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 83340
- Address
- 1 Baxter Pkwy
- Code information
- Lot #s: P389684; P389742, Exp. 8/31/2020
- Postal code
- 60015-4625
- Report date
- Jul 31, 2019
- Product type
- Drugs
- Recall number
- D-1514-2019
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Product quantity
- 139,680 Containers
- Termination date
- Apr 19, 2021
- Reason for recall
- Lack of Assurance of Sterility: Bags have potential to leak.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection USP, 100 mL Viaflex Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38.
- Distribution pattern
- Nationwide in the United States and Puerto Rico.
- Recall initiation date
- Jul 18, 2019
- Initial firm notification
- Letter
- Center classification date
- Jul 23, 2019