Why it was recalled
Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.
Product description
0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38
Lot numbers, UPCs & expiration codes
Lot #: P329821, Exp 08/31/2016
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-1816-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 2, 2015
- FDA report date
- Sep 30, 2015
- Quantity
- 139,104 Bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-1816-2015, exactly as published.
Show all FDA fields
- City
- Jayuya
- State
- PR
- Status
- Terminated
- Country
- United States
- Event ID
- 72060
- Address
- Road #144, #250
- Code information
- Lot #: P329821, Exp 08/31/2016
- Postal code
- 00664-1503
- Report date
- Sep 30, 2015
- Product type
- Drugs
- Recall number
- D-1816-2015
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Product quantity
- 139,104 Bags
- Termination date
- Sep 15, 2016
- Reason for recall
- Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection, USP, 100 mL MINI-BAG VIAFLEX Container, Single Dose Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-0049-38
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Sep 2, 2015
- Initial firm notification
- Letter
- Center classification date
- Sep 18, 2015