Adenosine Injection
Lack of Assurance of Sterility
Class I — High risk. Reasonable probability of serious harm or death.
Non Sterility; microbial contamination identified as Aspergillus species
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pharmacy Services, Inc., Livonia, MI 48150
Drug: Adenosine
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of sterility assurance.
Lack of Sterility Assurance.
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Incorrect Product Formulation
Incorrect product formulation: bag did not contain copper and famotidine per label.
Presence of Particulate Matter
Lack of assurance of sterility:
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