Class II · Moderate risk Terminated
Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate 12.5%), packaged in a) 3 fl. oz. roll-on (NDC…
Reason CGMP Deviations
FDA Drug Recalls
948 recalls · Class II, newest first
Class II · Moderate risk Terminated
Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 30775-051-01), b) 3 fl. oz. roll-on (NDC 30775-051-03)…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2 fl oz/60 mL Pump bottles (NDC 30775-040-02) and…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279…
Reason cGMP deviations: Batch was released prior to approval.
Class II · Moderate risk Terminated
Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279…
Reason cGMP deviations: Batch was released prior to approval.
Class II · Moderate risk Completed
Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules per carton, Rx Only, For Oral Use Only - Not For…
Reason CGMP deviation: product released prior to supplier approval.
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
morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935…
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
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
PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite…
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite…
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
rocuronium, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite…
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935…
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
lidocaine 2%, 100 mg /5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC…
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
ePHEDrine in 0.9% sodium chloride, 50 mg /5 mL, (10 mg/mL), 5 mL Syringe, Rx only, CAPS Inc., Inc., 7935 Dunbrook Road, Suite C…
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
ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San…
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
Class II · Moderate risk Terminated
morphine in 0.9% sodium chloride, 125 mg/25 mL, (5 mg/mL), 30 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 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
Class II · Moderate risk Terminated
PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services…
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
morphine in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935…
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
morphine in 0.9% sodium chloride, 1 mg/1 mL, (1 mg/mL), 3 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935…
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc…
Reason Lack of assurance of sterility: Lack of validation data for sanitization cycles