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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 341–360 of 1,000 recalls

Class ITerminated

Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01

Marlex Pharmaceuticals, Inc.

Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.

August 25, 2023 · DrugView details →
Class ITerminated

WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar Code X00358V0O5

Hua Da Trading, Inc. dba Wefun Inc.

Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil, an ingredient found in a FDA approved product for the treatment of male sexual enhancement, making this an unapproved drug.

August 25, 2023 · Drug
View details →
Class IITerminated

Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC 0338-0067-01

Baxter Healthcare Corporation

CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.

August 24, 2023 · DrugView details →
Class IIITerminated

Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only, Manufactured by: Contract Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, Manufactured for: Glasshouse Pharmaceuticals Limited Canada, Mississauga, Ontario, Canada, NDC# 71428-003-60

Contract Pharmaceuticals Limited Canada

Defective Container: slow leakage under the cap

August 23, 2023 · DrugView details →
Class IITerminated

Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1 multi-dose glass vial, Diagnostic-For Intravenous Use Only, Manufactured by SOFIE Co dba SOFIE, Dulles, VA 20166 for Life Molecular Imagining Ltd., NDC 54828-001-50

Sofie Co dba Sofie

Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity Test (FIT).

August 22, 2023 · DrugView details →
Class IITerminated

EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7018-1.

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, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6030-1.

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) 3.5%/Dextrose 10% with HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0431-1

Central Admixture Pharmacy Services, Inc.

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

August 17, 2023 · DrugView details →
Class IITerminated

heparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-8100-1

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) 3.5%/Dextrose 10%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0406-1

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 50 mg/250mL (200mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043. NDC:72196-7039-1

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%, Total Volume = 250mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0404-1

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 **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0428-1

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, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High Potassium, EVA Bags, total volume = 500 mL, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0111-1

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) 3.5% / Dextrose 10% with **low calcium** and HEPARIN, IV Bag, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0429-1

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 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-6044-1

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, 20mg/250ml (80 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-7025-1.

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, 10mg/250ml (40mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6058-1.

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 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 72196-6055-1

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) 4%/Dextrose 10% with CALCIUM and HEPARIN, IV Bags, total volume = 250mL, Rx only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue, Pheonix, AZ 85043, NDC: 72196-0422-1

Central Admixture Pharmacy Services, Inc.

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

August 17, 2023 · DrugView details →
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