Why it was recalled
Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.
Product description
0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0553-11
Lot numbers, UPCs & expiration codes
Lot: P293118; Exp Date: 10/13
Where it was sold
Nationwide and Singapore
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-623-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 27, 2013
- FDA report date
- Jul 3, 2013
- Quantity
- 317,280 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp.
Original FDA data
Every field from FDA enforcement report D-623-2013, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 65061
- Address
- 1 Baxter Pkwy
- Code information
- Lot: P293118; Exp Date: 10/13
- Postal code
- 60015-4625
- Report date
- Jul 3, 2013
- Product type
- Drugs
- Recall number
- D-623-2013
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corp.
- Product quantity
- 317,280 bags
- Termination date
- May 11, 2015
- Reason for recall
- Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injection , USP 100 mL in MINI-BAG Plus container instead of 50 mL.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, distributed by Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0553-11
- Distribution pattern
- Nationwide and Singapore
- Recall initiation date
- Feb 27, 2013
- Initial firm notification
- Letter
- Center classification date
- Jun 27, 2013