Central Admixture Pharmacy Services oxyTOCIN 15 units added to Lactated Ringer's 250 mL, IV recall — FDA D-0975-2023
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
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Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Lack of assurance of sterility: Lack of validation data for sanitization cycles
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
cGMP deviations: due to shipment of rejected units.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Defective Delivery System
Lack of Assurance of Sterility
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Lack of Assurance of Sterility
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Lack of Assurance of Sterility
CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Superpotent Drug: Out of Specification (OOS) results observed for unit dose content.
Lack of Assurance of Sterility
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