Why it was recalled
Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
Product description
0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.
Lot numbers, UPCs & expiration codes
Lot#: P327635, Exp 12/15
Where it was sold
Nationwide
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-1335-2015
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jul 17, 2015
- FDA report date
- Aug 26, 2015
- Quantity
- 133,600 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corp.
Original FDA data
Every field from FDA enforcement report D-1335-2015, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 71749
- Address
- 1 Baxter Pkwy
- Code information
- Lot#: P327635, Exp 12/15
- Postal code
- 60015-4625
- Report date
- Aug 26, 2015
- Product type
- Drugs
- Recall number
- D-1335-2015
- Classification
- Class I
- Recalling firm
- Baxter Healthcare Corp.
- Product quantity
- 133,600 bags
- Termination date
- Dec 1, 2016
- Reason for recall
- Presence of Particulate Matter: Customer complaint for an insect found free floating inside a single bag for each lot recalled.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 17, 2015
- Initial firm notification
- Letter
- Center classification date
- Aug 14, 2015