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FDA Recalls
›Drug Recalls

FDA Drug Recalls

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

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 1901–1920 of 17,711 recalls

Class IITerminated

oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6039-1

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · DrugView details →

Class IITerminated

oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8069-1

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · DrugView details →

Class IITerminated

PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6009-1

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · DrugView details →

Class IITerminated

rocuronium 50 mg/5 mL (10 mg/mL), 5 mL Syringes, Rx only, this drug was repackaged by CAPS Inc, 2200 South 43rd Avenue, Pheonix, AZ, NDC 72196-6010-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · DrugView details →

Class IITerminated

Neonatal TPN Starter Bag, Amino Acids (Trophamine) 2.5%/Dextrose 10% with CALCIUM and HEPARIN, total volume = 250mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0418-1

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · DrugView details →

Class IITerminated

PHENYLephrine, added to 0.9% sodium chloride, 40mg/250ml (160mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6092-1

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · DrugView details →

Class IITerminated

Cardioplegia Solution del Nido Formula, Total Volume = 1,052.8 mL, EVA Bag, PLASMA-LYTE A 1000 mL, Mannitol 20% 16.3 mL, Sodium Bicarbonate 8.4% 13 mL, Potassium Chloride 2 mEq/mL 13 mL, Magnesium Sulfate 4.06 mEq/mL 4 mL, Lidocaine 2% 6.5 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0202-1

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · DrugView details →

Class IITerminated

CARDIOPLEGIA SOLUTION, 20 mEq K, Maintenance 4:1, Low Potassium, Total Volume = 810 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-0103-1

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · DrugView details →

Class IITerminated

Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 10% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0420-1

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · DrugView details →

Class IITerminated

CARDIOPLEGIA SOLUTION, 24 mEq K, Maintenance 8:1, Low Potassium, Total volume = 500 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0105-1

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · DrugView details →

Class IITerminated

dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6054-1

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · DrugView details →

Class IITerminated

Cardioplegia Solution, low K, Maintenance 4:1 Plasmalyte, Low Potassium, total volume = 1047 mL, EVA Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0211-1

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · DrugView details →

Class IITerminated

EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-8093-1.

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · DrugView details →

Class IITerminated

Neonatal TPN Starter Bag, Amino Acids (trophamine) 3%/Dextrose 5% with CALCIUM and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043. NDC: 72196-0419-1

Central Admixture Pharmacy Services, Inc.

Lack of Assurance of Sterility:Lack of validation data for sanitization cycles

August 17, 2023 · DrugView details →

Class IIICompleted

Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc, Ann Arbor, MI 48108, NDC 72426-818-03

Esperion

Failed dissolution specifications: below specification results at stability 12-month

August 16, 2023 · DrugView details →

Class IITerminated

Semaglutide/Cyanocobalamin 2mg/0.4mg/mL, 1mLvials, Tailor Made Compounding.

TMC Acquisitions LLC dba Tailor Made Compounding

Lack of Assurance of Sterility

August 15, 2023 · DrugView details →

Class IITerminated

NAD+ 200mg/ml, 10ml vials, Tailor Made Compounding.

TMC Acquisitions LLC dba Tailor Made Compounding

Lack of Assurance of Sterility

August 15, 2023 · DrugView details →

Class IIITerminated

Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single vial), Rx only, Distributed by: Armas Pharmaceuticals, Inc. Freehold, NJ 07728(USA) Manufactured by: Caplin Steriles Limited, India, NDC 72485-502-10

Caplin Steriles Limited

Failed Impurities/Degradation Specifications

August 14, 2023 · DrugView details →

Class IIOngoing

All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar.

Inmar Supply Chain Solutions, LLC

CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage condition instructions on product labeling.

August 14, 2023 · DrugView details →

Class IIICompleted

Bendamustine HCl Injection, 100mg/4mL (25mg/mL), One 4 mL Multiple-Dose Vial, Rx only, Manufactured for Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 10019-079-01.

Baxter Healthcare Corporation

Labeling: Missing Label; customer complaint received that labels were partially or completely peeled off injection vial.

August 14, 2023 · DrugView details →

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