Why it was recalled
Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
Product description
0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code 2B0043, NDC 0338-0553-18.
Lot numbers, UPCs & expiration codes
Lot #: P317891, P317842, Exp 05/15
Where it was sold
Nationwide 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-481-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Dec 4, 2014
- FDA report date
- Apr 15, 2015
- Quantity
- 542,080 container bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp
Original FDA data
Every field from FDA enforcement report D-481-2015, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69962
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: P317891, P317842, Exp 05/15
- Postal code
- 60015-4625
- Report date
- Apr 15, 2015
- Product type
- Drugs
- Recall number
- D-481-2015
- Classification
- Class I
- Recalling firm
- Baxter Healthcare Corp
- Product quantity
- 542,080 container bags
- Termination date
- Apr 14, 2017
- Reason for recall
- Presence of Particulate Matter: Confirmed customer complaints received for the presence of blue plastic, identified as fragments of the frangible from the vial adapter.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection USP, 100 mL MINI-BAG Plus Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, Product Code 2B0043, NDC 0338-0553-18.
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- Dec 4, 2014
- Initial firm notification
- Letter
- Center classification date
- Apr 8, 2015