Why it was recalled
Lack of assurance of sterility: customer complaints received for the presence of leaks.
Product description
Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-6010-48
Lot numbers, UPCs & expiration codes
Lot #: P342485, Exp 11/30/17; P344408, Exp 12/31/17
Where it was sold
US and foreign countries: United Arab Emirates, Colombia, and Canada
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-0789-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 15, 2017
- FDA report date
- May 24, 2017
- Quantity
- 90,450 bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-0789-2017, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 77247
- Address
- 1 Baxter Pkwy
- Code information
- Lot #: P342485, Exp 11/30/17; P344408, Exp 12/31/17
- Postal code
- 60015-4625
- Report date
- May 24, 2017
- Product type
- Drugs
- Recall number
- D-0789-2017
- Classification
- Class II
- Recalling firm
- Baxter Healthcare Corporation
- Product quantity
- 90,450 bags
- Termination date
- Aug 10, 2018
- Reason for recall
- Lack of assurance of sterility: customer complaints received for the presence of leaks.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-6010-48
- Distribution pattern
- US and foreign countries: United Arab Emirates, Colombia, and Canada
- Recall initiation date
- May 15, 2017
- Center classification date
- May 18, 2017