Class II · Moderate risk Terminated
Oxytocin 30 units added to 500 mL Lactated Ringer's USP in 500 mL bag Rx Only, Compounded by PharMEDium Services, LLC. 12620 W…
Reason Subpotent Drug
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
Oxytocin 30 units added to 500 mL 5% Dextrose/Lactated Ringer's USP in 500 mL bag, Rx Only, Compounded by PharMEDium Services…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 30 units added to 1000 mL 5% Dextrose/Lactated Ringer's USP in 1000 mL bag, Rx Only, Compounded by PharMEDium Services…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 20 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag Rx Only, Compounded by PharMEDium Services, LLC…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag Rx Only, Compounded by PharMEDium Services…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 20 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx Only, Compounded by PharMEDium Services…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 15 units added to 250 mL Lactated Ringer's Injection USP in 250 mL bag, Rx Only, Compounded by PharMEDium Services, LLC…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 10 units added to 500 mL Lactated Ringer's Injection USP in 500 mL bag ,Rx Only , Compounded by PharMEDium Services…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 10 units added to 1000 mL Lactated Ringer's Injection USP in 1000 mL bag, Rx Only , Compounded by PharMEDium Services…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentration: 0.06 units/mL. This is a compounded injectable…
Reason Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product…
Class II · Moderate risk Terminated
Oxytocin all strengths, all dosage forms and all packaging, Rx Only, Avella of Houston, Houston, TX 77054
Reason Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Class II · Moderate risk Terminated
Oxytocin 30 USP Units Added to 0.9% Sodium Chloride, 500 mL Bag, Single-Dose Bag, Injection Solution for IV Use Only, Rx Only…
Reason Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Class II · Moderate risk Terminated
Oxytocin 20 Units added to Lactated Ringers in a 1000 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Oxytocin 30 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Oxytocin 20 Units added to 0.9% Sodium Chloride in a 1000mL lntravia bag, Compounded by PHARMAKON Pharmaceuticals, Noblesville…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Oxytocin 100 units/ml Injection, Multi-Dose Vial, Sterile, Refrigerate, The Compounding Pharmacy of America, Knoxville, TN
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class I · High risk Terminated
oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP, packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W…
Reason Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were…
Class II · Moderate risk Terminated
Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags, Not for Dispensing, For Hospital Administration Only, Rx Formulations, 5949…
Reason Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to lack of assurance of sterility from poor aseptic…
Class II · Moderate risk Terminated
OXYTOCIN 10 UNITS/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical…
Reason Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility…
Class II · Moderate risk Terminated
Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx Only, 1 mL vial, APP ) 10 USP Units/mL, 1…
Reason Subpotent Drug; 15-month stability test station
Class II · Moderate risk Ongoing
Oxytocin 20 units/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class III · Low risk Terminated
Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured and Distributed by: JHP Pharmaceuticals…
Reason Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of…
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