🍔 Food 💊 Drugs 🏥 Medical Devices
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 Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-64, Bar Code 70004023164 Class II

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated
Distributed: Nationwide in the USA
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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 Rd., Windsor, CT 06095, NDC 70004-0231-32, Bar Code 70004023132 Class II

Reason: Lack of Assurance of Sterility

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

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated
Distributed: Nationwide in the USA
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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 BAR code 70004022940 Class II

Reason: Lack of Assurance of Sterility

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

Reason: Lack of Assurance of Sterility

SCA Pharmaceuticals, LLC 20231109 Terminated
Distributed: Nationwide in the USA
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Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, Distributed By Superchill Products, 827 6th Avenue, New York, New York 10001. Class I

Reason: Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

Super Chill Products 20240205 Terminated
Distributed: Nationwide in the U.S.
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Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ 07922, NDC 0641-6039-01 Class II

Reason: The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.

Hikma Pharmaceuticals USA Inc. 20240312 Ongoing
Distributed: Nationwide within the United States
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Nicardipine Hydrochloride Injection, USP 25mg/mL (2.5 mg/mL) 10 mL vials, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, NDC 55150-183-11 Class II

Reason: Failed Impurities/Degradation Specifications: Out of specification for organic impurities

Eugia US LLC 20240220 Ongoing
Distributed: Nationwide within the United States
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Nicardipine Hydrochloride Injection (2.5mg/mL), US, 25mg per 10mL, 10mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 NDC 55150-183-10 Class II

Reason: Failed Impurities/Degradation Specifications: Out of specification for organic impurities

Eugia US LLC 20240220 Ongoing
Distributed: Nationwide within the United States
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Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Drive, East Windsor, New Jersey 08520, NDC 70954-201-20 Class III

Reason: Cross Contamination with Other Products:(mycophenolate mofetil).

Novitium Pharma LLC 20240304 Terminated
Distributed: Nationwide in the USA
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