Is Oxytocin recalled?
76 FDA recalls mention Oxytocin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Oxytocin.
Class II · Moderate risk Terminated Apr 28, 2023
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated Apr 28, 2023
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated Apr 28, 2023
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class III · Low risk Terminated Apr 10, 2023
Reason Subpotent Drug: Out of specification results for low potency was obtained.
Class III · Low risk Terminated Sep 20, 2022
Reason Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
Class II · Moderate risk Terminated Jun 30, 2022
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated May 18, 2022
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated May 28, 2020
Reason Subpotent drug - Product did not contain drug.
Class II · Moderate risk Terminated Sep 12, 2019
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated Jun 12, 2019
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated Apr 12, 2019
Reason Lack of sterility assurance.
Class III · Low risk Terminated Feb 6, 2019
Reason Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class III · Low risk Terminated Feb 6, 2019
Reason Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class III · Low risk Terminated Feb 6, 2019
Reason Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class II · Moderate risk Terminated Sep 10, 2018
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated Mar 7, 2018
Reason Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Class II · Moderate risk Terminated Feb 5, 2018
Reason Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may…
Class II · Moderate risk Terminated Nov 16, 2017
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk Terminated Oct 19, 2017
Reason Lack Of Assurance Of Sterility.
Class II · Moderate risk Terminated Oct 10, 2017
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated Sep 1, 2017
Reason Subpotent Drug
Class II · Moderate risk Terminated Sep 1, 2017
Reason Subpotent Drug
Class II · Moderate risk Terminated Sep 1, 2017
Reason Subpotent Drug
Class II · Moderate risk Terminated Sep 1, 2017
Reason Subpotent Drug
Class II · Moderate risk Terminated Sep 1, 2017
Reason Subpotent Drug