45 FDA recalls mention Succinylcholine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Succinylcholine.
Reason Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Reason Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any individual unknown degradation impurity.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of assurance of sterility:
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Reason CGMP Violations- that spaces adjacent to the production area may have been compromised at the time of production.
Reason Lack of Assurance of Sterility
Reason CGMP Deviations: recalling drug products following an FDA inspection.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of sterility assurance
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Reason Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making…
Reason Firm is recalling 46 lots of various products because of a lack of sterility assurance.
Reason Incorrect labeling: Incorrect or missing lot and/or exp date
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: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific…
Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific…
Reason Lack of sterility assurance.
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