🍔 Food 💊 Drugs 🏥 Medical Devices
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, Bar Code 7004030317 Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated
Distributed: Nationwide in the USA
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HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022 Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated
Distributed: Nationwide in the USA
View Details
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 70004030018 Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated
Distributed: Nationwide in the USA
View Details
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 70004-0300-16, Bar Code 70004030016 Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated
Distributed: Nationwide in the USA
View Details
HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar Code 70004030063 Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated
Distributed: Nationwide in the USA
View Details
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, Bar code 70004020022, Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated
Distributed: Nationwide in the USA
View Details
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, NDC 70004-0200-17, Bar code 70004020017 Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated
Distributed: Nationwide in the USA
View Details
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 Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0251-64, Bar Code 70004025164 Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated
Distributed: Nationwide in the USA
View Details
fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 5 mcg/mL), EPIDURAL USE ONLY, 100 mL Yellow CADD Cassette, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0289-64, Bar Code 70004028964 Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated
Distributed: Nationwide in the USA
View Details
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 Rainbow Rd, Windsor, CT 06095, NDC 70004-0231-22, Bar Code 70004023122 Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated
Distributed: Nationwide in the USA
View Details
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