🍔 Food 💊 Drugs 🏥 Medical Devices
Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44 Class III

Reason: Subpotent Drug: Out of specification results for low potency was obtained.

SCA Pharmaceuticals 20230410 Terminated
Distributed: Nationwide in the USA
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Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-487-52 Class II

Reason: CGMP Deviations

Northwind Pharmaceuticals LLC 20230316 Ongoing
Distributed: Nationwide with the United States
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Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473-54), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. Class II

Reason: CGMP Deviations

Northwind Pharmaceuticals LLC 20230316 Ongoing
Distributed: Nationwide with the United States
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Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. Class II

Reason: CGMP Deviations

Northwind Pharmaceuticals LLC 20230316 Ongoing
Distributed: Nationwide with the United States
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Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. Class II

Reason: CGMP Deviations

Northwind Pharmaceuticals LLC 20230316 Ongoing
Distributed: Nationwide with the United States
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Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-109-52 Class II

Reason: CGMP Deviations

Northwind Pharmaceuticals LLC 20230316 Ongoing
Distributed: Nationwide with the United States
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BusPIRone Hydrochloride Tablets USP, 7.5 mg, 30-count bottles, Rx Only, Repackaged By: NOrthwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-511-52 Class II

Reason: CGMP Deviations

Northwind Pharmaceuticals LLC 20230316 Ongoing
Distributed: Nationwide with the United States
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Atorvastatin Calcium Tablets, USP, 10 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-946-52 Class II

Reason: CGMP Deviations

Northwind Pharmaceuticals LLC 20230316 Ongoing
Distributed: Nationwide with the United States
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Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark. Class III

Reason: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

DuPont Nutrition USA, Inc 20230413 Terminated
Distributed: Nationwide in the USA, Malta, Canada, China, Peru, Mexico, Australia, Saudi Arabia, Spain, Dominican Republic, Puerto Rico, Singapore, Bangkok, Ireland, India, and Columbia.
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Avicel PH-200 NF, Microcrystalline Cellulose NF, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark. Class III

Reason: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

DuPont Nutrition USA, Inc 20230413 Terminated
Distributed: Nationwide in the USA, Malta, Canada, China, Peru, Mexico, Australia, Saudi Arabia, Spain, Dominican Republic, Puerto Rico, Singapore, Bangkok, Ireland, India, and Columbia.
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