Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
Reason: Lack of assurance of sterility: bags have the potential to leak..
D-0431-2024April 10, 2024Irvine, CA
SSM Health Care St. Louis DBA SSM St. Clare Health Center
Class IIOngoing
Phenylephrine HCl, 1000 mcg/10 mL, 10 mL Total Volume per syringe, Intravenous, Rx Only, Hospital/Office Use Only, This is a Compounded Drug - Not for Resale, SSM Health Care Corporation Outsourcing F...
Reason: Lack of Assurance of Sterility: Firm did not perform process validation.
SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 mL fill 12 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-12, Bar Code 7...
Reason: Lack of Assurance of Sterility
D-0423-2024April 3, 2024Windsor, CT
SCA Pharmaceuticals, LLC
Class IITerminated
fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = 10 mcg/mL), 250 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, 877.550.5059, NDC 70004-0229-40 B...
Reason: Lack of Assurance of Sterility
D-0395-2024April 3, 2024Windsor, CT
SCA Pharmaceuticals, LLC
Class IITerminated
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection, (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceutic...
Reason: Lack of Assurance of Sterility
D-0398-2024April 3, 2024Windsor, CT
SCA Pharmaceuticals, LLC
Class IITerminated
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810...
Reason: Lack of Assurance of Sterility
D-0416-2024April 3, 2024Windsor, CT
SCA Pharmaceuticals, LLC
Class IITerminated
fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS USE ONLY, 50 mL Bag, Rx only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0222-30 BAR code 70004022230
Reason: Lack of Assurance of Sterility
D-0396-2024April 3, 2024Windsor, CT
SCA Pharmaceuticals, LLC
Class IITerminated
SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL fill 6 mL Syringe, Rx only, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0908-09, Bar Code 7000...
Reason: Lack of Assurance of Sterility
D-0424-2024April 3, 2024Windsor, CT
SCA Pharmaceuticals, LLC
Class IITerminated
PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 40 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-081...
Reason: Lack of Assurance of Sterility
D-0418-2024April 3, 2024Windsor, CT
SCA Pharmaceuticals, LLC
Class IITerminated
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095; NDC 70004-0541-35, Bar Code 70004054135
Reason: Lack of Assurance of Sterility
D-0394-2024April 3, 2024Windsor, CT
SCA Pharmaceuticals, LLC
Class IITerminated
fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22, ...
Reason: Lack of Assurance of Sterility
D-0403-2024April 3, 2024Windsor, CT
SCA Pharmaceuticals, LLC
Class IITerminated
HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL), 25 mL fill 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-17...
Reason: Lack of Assurance of Sterility
D-0408-2024April 3, 2024Windsor, CT
SCA Pharmaceuticals, LLC
Class IITerminated
PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0...
Reason: Lack of Assurance of Sterility
D-0414-2024April 3, 2024Windsor, CT
SCA Pharmaceuticals, LLC
Class IITerminated
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 0.2 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC ...
Reason: Lack of Assurance of Sterility
D-0405-2024April 3, 2024Windsor, CT
SCA Pharmaceuticals, LLC
Class IITerminated
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar ...
Reason: Lack of Assurance of Sterility
D-0410-2024April 3, 2024Windsor, CT
SCA Pharmaceuticals, LLC
Class IITerminated
HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/ml) 30 mL Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-18, Bar Code 700040300...
Reason: Lack of Assurance of Sterility
D-0406-2024April 3, 2024Windsor, CT
SCA Pharmaceuticals, LLC
Class IITerminated
HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70...
Reason: Lack of Assurance of Sterility
D-0409-2024April 3, 2024Windsor, CT
SCA Pharmaceuticals, LLC
Class IITerminated
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceutica...
Reason: Lack of Assurance of Sterility
D-0401-2024April 3, 2024Windsor, CT
SCA Pharmaceuticals, LLC
Class IITerminated
fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rai...
Reason: Lack of Assurance of Sterility
D-0399-2024April 3, 2024Windsor, CT
SCA Pharmaceuticals, LLC
Class IITerminated
PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar...
Reason: Lack of Assurance of Sterility
D-0417-2024April 3, 2024Windsor, CT
SCA Pharmaceuticals, LLC
Class IITerminated
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow R...
Reason: Lack of Assurance of Sterility
D-0397-2024April 3, 2024Windsor, CT
SCA Pharmaceuticals, LLC
Class IITerminated
neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL fill 6 mL Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0750-09, Bar Code 70004075009
Reason: Lack of Assurance of Sterility
D-0413-2024April 3, 2024Windsor, CT
SCA Pharmaceuticals, LLC
Class IITerminated
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 SCA Pharma. SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, ND...
Reason: Lack of Assurance of Sterility
D-0402-2024April 3, 2024Windsor, CT
SCA Pharmaceuticals, LLC
Class IITerminated
labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028