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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 2141–2160 of 17,711 recalls

Class IITerminated

Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA 02451, NDC # 49230-300-10

Fresenius Medical Care Holdings, Inc.

Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.

May 23, 2023 · DrugView details →
Class IICompleted

Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015; NDC 0363-9947-35.

Aurobindo Pharma USA Inc.

Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.

May 22, 2023 · DrugView details →
Class IIITerminated

Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Woburn, Massachusetts 01801-1042 United States, NDC 71546-451-25

New England Life Care, Inc. dba Advanced Compounding Solutions

Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride

May 22, 2023 · DrugView details →
Class IIOngoing

Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99

Sagent Pharmaceuticals Inc

Lack of Assurance of Sterility

May 19, 2023 · DrugView details →
Class IIOngoing

Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10

Sagent Pharmaceuticals Inc

Lack of Assurance of Sterility

May 19, 2023 · DrugView details →
Class IIOngoing

Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10

Sagent Pharmaceuticals Inc

Lack of Assurance of Sterility

May 19, 2023 · DrugView details →
Class IIITerminated

Glycopyrrolate Tablets, USP, 1 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01

Aurolife Pharma, LLC

Failed Impurities/Degradation Specifications

May 18, 2023 · DrugView details →
Class IITerminated

FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC industrial Park, Pittsburgh, PA 15238,

Alpha Aromatics

CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

May 16, 2023 · DrugView details →
Class IITerminated

Piperacillin and Tazobactam for Injection, USP 4.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-004-51

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class IITerminated

Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-005-20

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class IITerminated

Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-098-01

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class IITerminated

Piperacillin and Tazobactam for Injection, USP, 3.375 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-217-41

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class IITerminated

Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-006-30

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class IITerminated

Ampicillin and Sulbactam for Injection, USP 3 grams vials, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-242-41

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class IITerminated

Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC 66794-212-42

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class IITerminated

Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017, NDC66794-216-41

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class IITerminated

Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-206-41

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class IITerminated

Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-090-02

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class IITerminated

Ampicillin for Injection, USP 2g per vial, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-223-41

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
Class IITerminated

Piperacillin and Tazobactam for Injection, USP 2.25 g per vial,s Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-078-02

Astral SteriTech Private Ltd.

Lack of Assurance of Sterility

May 15, 2023 · DrugView details →
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