Class I — High risk. Reasonable probability of serious harm or death.
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
Nexterone (amiodarone HCl) Premixed Injection, 150mg/100mL, 100-mL bag, Rx Only, Sterile, Baxter Healthcare Corporation, Deerfield, IL. NDC 43066-150-10
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons…
Reason Crystallization: Presence of visible particulate matter.
Reason Crystallization: Presence of visible particulate matter.
Reason Crystallization: Presence of visible particulate matter.
Reason Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product…
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