EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services…
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
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Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason Presence of Foreign Substance: Metal embedded in a tablet.
Reason CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Reason CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Reason CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Reason CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Reason Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Reason Lack of assurance of sterility: bags have the potential to leak.
Reason Failed Moisture Limits: Water (moisture) content above the approved product specifications.