8 FDA recalls mention Amiodarone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Amiodarone.
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 Presence of Particulate Matter:Particulate identified as polyethylene, the primary constituent of the film and ports used to manufacture the bag in…
Reason Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product…
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Reason Temperature Abuse: One shipment was inadvertantly stored refrigerated rather than the labeled room temperature recommendation at McKesson…
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