Why it was recalled
Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
Product description
Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10
Lot numbers, UPCs & expiration codes
Lot #, Expiry: NC109925, Exp 6/1/2019; NC109123, 5/2019
Where it was sold
Nationwide within USA 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-0573-2018
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 10, 2017
- FDA report date
- Feb 7, 2018
- Quantity
- 35,628 single-dose containers
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Baxter Healthcare Corporation
Original FDA data
Every field from FDA enforcement report D-0573-2018, exactly as published.
Show all FDA fields
- City
- Deerfield
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 78531
- Address
- 1 Baxter Pkwy
- Code information
- Lot #, Expiry: NC109925, Exp 6/1/2019; NC109123, 5/2019
- Postal code
- 60015-4625
- Report date
- Feb 7, 2018
- Product type
- Drugs
- Recall number
- D-0573-2018
- Classification
- Class I
- Recalling firm
- Baxter Healthcare Corporation
- Product quantity
- 35,628 single-dose containers
- Termination date
- Aug 29, 2018
- Reason for recall
- Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in which product is packaged
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10
- Distribution pattern
- Nationwide within USA and Puerto Rico
- Recall initiation date
- Nov 10, 2017
- Initial firm notification
- Letter
- Center classification date
- Mar 1, 2018