fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL…
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
356 FDA recalls mention Fentanyl. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Fentanyl.
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Labeling: Incorrect or Missing Package Insert
Reason Labeling: Incorrect or Missing Package Insert
Reason Labeling: Incorrect or Missing Package Insert
Reason Labeling: Incorrect or Missing Package Insert
Reason Labeling: Incorrect or Missing Package Insert
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Subpotent Drug
Reason Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
Reason Short Fill: Underfilled units.
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