Class II · Moderate risk Terminated
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL)…
Reason Lack of Assurance of Sterility
Is Fentanyl recalled?
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.
Class II · Moderate risk Terminated
fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL, 1,250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL, 5,000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
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:
Class II · Moderate risk Terminated
fentaNYL in 0.9% sodium chloride, 5,000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL in 0.9% sodium chloride, 100 mcg/10 mL, (10 mcg/mL), 10 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc…
Reason Lack of assurance of sterility:
Class II · Moderate risk Terminated
FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL Bag, Injection for Epidural Use (fentaNYL…
Reason cGMP deviations: due to shipment of rejected units.
Class II · Moderate risk Terminated
fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc…
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, bag…
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total Volume = 100 mL, Total FentaNYL 200 mcg/100 mL, 100…
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total Volume = 250 mL, Total fentaNYL 500 mcg/250 mL, 250…
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
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