🍔 Food 💊 Drugs 🏥 Medical Devices
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 70004-0811-12, Bar Code 70004081112. Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated
Distributed: Nationwide in the USA
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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 Code 70004081022. Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated
Distributed: Nationwide in the USA
View Details
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 70004-0810-11-K, Bar Code 70004081011. (same finished product as F078140, but with RFID for KitCheck Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated
Distributed: Nationwide in the USA
View Details
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 70004-0810-11, Bar Code 70004081011 Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated
Distributed: Nationwide in the USA
View Details
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 70004-0810-12, Bar Code 70004081012 Class II

Reason: Lack of Assurance of Sterility

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

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated
Distributed: Nationwide in the USA
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Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 70004041159 Class II

Reason: Lack of Assurance of Sterility

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

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated
Distributed: Nationwide in the USA
View Details
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 Code 70004030321 Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated
Distributed: Nationwide in the USA
View Details
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 70004-0303-16, Bar Code 70004030316 Class II

Reason: Lack of Assurance of Sterility

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