Recalls / Class I
Class ID-0573-2018
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10
- Brand name
- Nexterone
- Generic name
- Amiodarone Hydrochloride
- Active ingredient
- Amiodarone Hydrochloride
- Route
- Intravenous
- NDCs
- 43066-150, 43066-360
- FDA application
- NDA022325
- Affected lot / code info
- Lot #, Expiry: NC109925, Exp 6/1/2019; NC109123, 5/2019
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
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Manufacturer
- Baxter Healthcare Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 35,628 single-dose containers
- Distribution pattern
- Nationwide within USA and Puerto Rico
Timeline
- Recall initiated
- 2017-11-10
- FDA classified
- 2018-03-01
- Posted by FDA
- 2018-02-07
- Terminated
- 2018-08-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0573-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.