Class II · Moderate risk Terminated
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only…
Reason Lack of Assurance of Sterility
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Class II · Moderate risk Terminated
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL)…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL)…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL)…
Reason Lack of Assurance of Sterility
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
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
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
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755…
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% Topical Gel), Single-use Topical Syringe, 3mL syringe…
Reason Product Mix-up: Incorrect Product Formulation
Class II · Moderate risk Terminated
Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family…
Reason cGMP Deviations
Class I · High risk Terminated
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc…
Reason Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing…