September 27, 2023DrugsFDA
AMMAN PHARMACEUTICAL INDUSTRIES recalls TRP Natural Eyes, Dryness Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusiv
Hazard: Lack of Assurance of Sterility
September 27, 2023DrugsFDA
AMMAN PHARMACEUTICAL INDUSTRIES recalls TRP Natural Eyes, Dryness Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusively
Hazard: Lack of Assurance of Sterility
September 27, 2023DrugsFDA
AMMAN PHARMACEUTICAL INDUSTRIES recalls TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 mL), Manufactured in Jordan, exclusively for
Hazard: Lack of Assurance of Sterility
September 27, 2023DrugsFDA
AMMAN PHARMACEUTICAL INDUSTRIES recalls TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusiv
Hazard: Lack of Assurance of Sterility
September 27, 2023DrugsFDA
AMMAN PHARMACEUTICAL INDUSTRIES recalls TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclus
Hazard: Lack of Assurance of Sterility
September 27, 2023DrugsFDA
AMMAN PHARMACEUTICAL INDUSTRIES recalls TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (10 mL), Manufactured in Jordan, exclusive
Hazard: Lack of Assurance of Sterility
September 20, 2023DrugsFDA
Hua Da Trading, Inc. dba Wefun Inc. recalls WEFUN Capsules 825 mg, 1x10 blister pack per carton, Manufactured by WEFUN Brooklyn NY 11204 www.eshoponlineusa.com Bar
Hazard: 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.
September 20, 2023DrugsFDA
VistaPharm LLC recalls Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL bottle), Rx Only, Manufactured and Distribu
Hazard: Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results
September 20, 2023DrugsFDA
BE PHARMACEUTICALS AG recalls Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-122-01 Packaged as (a) 10 Single-dose vials
Hazard: Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials.
September 13, 2023DrugsFDA
Marlex Pharmaceuticals, Inc. recalls Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc.
Hazard: 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.
September 13, 2023DrugsFDA
Marlex Pharmaceuticals, Inc. recalls Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc.
Hazard: 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.
September 13, 2023DrugsFDA
AVKARE LLC recalls Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, Manuf
Hazard: Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
September 13, 2023DrugsFDA
AVKARE LLC recalls Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System Spearm
Hazard: Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
September 13, 2023DrugsFDA
Ascend Laboratories, LLC recalls Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratorie
Hazard: Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
September 13, 2023DrugsFDA
Caplin Steriles Limited recalls Milrinone Lactate Injection, USP 20mg/20 mL (1mg/mL), packaged in 10 x 20 mL vials per carton, NDC 72485-502-01 (single
Hazard: Failed Impurities/Degradation Specifications
September 13, 2023DrugsFDA
Esperion recalls Nexlizet (bempedoic acid and ezetimibe), 180ng/18mg, 30 tablets, Rx only, Manufactured for: Esperion Therapeutics, Inc,
Hazard: Failed dissolution specifications: below specification results at stability 12-month
September 6, 2023DrugsFDA
APG SEVEN, INC recalls Vegetal Vigra, 200mg capsules, 8-count bottle, Manufacturer: Hand-shaking (Int'l) Corp. USA ADD: Hand-shaking Mansion, t
Hazard: 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.
September 6, 2023DrugsFDA
Lundbeck LLC recalls Sabril (vigabatrin) for Oral Solution, 500 mg, 50 Packets, Rx only, Manufactured by: Patheon, Cincinnati, OH 45237, NDC
Hazard: Cross contamination with other products
September 6, 2023DrugsFDA
Baxter Healthcare Corporation recalls Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FLEX ll Container with yellow pull ring, Rx O
Hazard: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
September 6, 2023DrugsFDA
Baxter Healthcare Corporation recalls DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, packaged in a) 2000 mL AMBU-FLEX II Containe
Hazard: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
September 6, 2023DrugsFDA
Contract Pharmaceuticals Limited Canada recalls Clindamycin Phosphate Topical Solution USP, 1%, 60 mL bottle, Rx only, Manufactured by: Contract Pharmaceuticals Limited
Hazard: Defective Container: slow leakage under the cap
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls dilTIAZem 125mg/125mL (1 mg/mL), added to dextrose 5%, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls dilTIAZem 125mg/125mL (1 mg/mL), added to 0.9% sodium chloride, IV Bag, Rx Only, Central Admixture Pharmacy Services, I
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls vancomycin added to 0.9% Sodium Chloride, 1.25 g/250 mL (5 mg/mL), 250mL Excel Bag, Rx only, Central Admixture Pharmacy
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls heparin added to 0.9% sodium chloride, 2500 units/500mL (5 units/mL), IV Bag, Rx only, Cental Admixture Pharmacy Service
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls oxyTOCIN, 40 units added to 0.9% sodium chloride 1000 mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 22
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls oxyTOCIN 30 units added to 0.9% sodium chloride 500 mL, IV Bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc.
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls oxyTOCIN 30 units added to Lactated Ringer's 500 mL, IV Bag, Rx only, Cental Admixture Pharmacy Services, Inc., 2200 Sou
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 220
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
September 6, 2023DrugsFDA
Central Admixture Pharmacy Services, Inc. recalls EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX only, Central Admixture Pharmacy Services,
Hazard: Lack of Assurance of Sterility:Lack of validation data for sanitization cycles