Why it was recalled
CGMP Deviations
Product description
0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18
Lot numbers, UPCs & expiration codes
Lot #: P380287, Exp. date 12/2019
Where it was sold
TX and MS only
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-1128-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 21, 2018
- FDA report date
- Sep 5, 2018
- Quantity
- 33600 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-1128-2018, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 80881
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: P380287, Exp. date 12/2019
- Postal code
- 60015-4625
- Report date
- Sep 5, 2018
- Product type
- Drugs
- Recall number
- D-1128-2018
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Product quantity
- 33600 bags
- Termination date
- Oct 30, 2019
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18
- Distribution pattern
- TX and MS only
- Recall initiation date
- Aug 21, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 27, 2018