Baxter Recalls Nexterone Injection Due to Polyethylene Particulate Matter
Baxter Healthcare is recalling Nexterone (amiodarone HCl) Premixed Injection because polyethylene particulate matter was identified in the product packaging.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Baxter Healthcare Corporation is recalling 35,628 single-dose containers of Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL. The recall was initiated because particulate matter was identified in the product. The particulate has been identified as polyethylene, which is the primary constituent of the film and ports used to manufacture the bag in which the product is packaged.
The affected product is a prescription-only, sterile, intravenous injection. The specific lots involved are NC109925 (Exp 6/1/2019) and NC109123 (Exp 5/2019). The product was distributed nationwide within the USA and Puerto Rico.
Healthcare providers and patients should stop using the affected lots of Nexterone. Baxter Healthcare is the recalling firm responsible for managing the recall.
The recalled product
- Product
- NEXTERONE (AMIODARONE HYDROCHLORIDE)
- Brand
- NEXTERONE
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Drug — Prescription Injection
- Affected units
- 35,628
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot #
- Expiry: NC109925
- Exp 6/1/2019
- NC109123
- 5/2019
Distribution
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