November 13, 2024DrugsFDA
Denison Pharmaceuticals, LLC recalls Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles furt
Hazard: Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
November 13, 2024DrugsFDA
Denison Pharmaceuticals, LLC recalls Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles fur
Hazard: Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
November 6, 2024DrugsFDA
ACCORD HEALTHCARE, INC. recalls Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-44
Hazard: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
November 6, 2024DrugsFDA
ACCORD HEALTHCARE, INC. recalls Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-44
Hazard: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
November 6, 2024DrugsFDA
ACCORD HEALTHCARE, INC. recalls Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440
Hazard: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
November 6, 2024DrugsFDA
BLI International, Inc. recalls Chlorpheniramine Maleate 4 mg tablets, 24-count bottle, Manufactured For: Athlete's Needs, Novi, MI 48377, NDC 53185-277
Hazard: Superpotent Drug: Stability failure for assay at 6 months test time-point.
November 6, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India.,
Hazard: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
November 6, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India,
Hazard: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
November 6, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, N
Hazard: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
October 30, 2024DrugsFDA
Akron Pharma, Inc. recalls OneLAX Docusate Sodium Liquid (docusate sodium 50 mg/5 mL) Stool Softener Laxative, 16 FL OZ (473 mL) bottle, Akron Phar
Hazard: CGMP Deviations
October 30, 2024DrugsFDA
C & A Naturistics recalls AK Forte Ortiga y Omega 3 Cont. Neto 100 Tabletas, 400 mg,
Hazard: Marketed without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared diclofenac and acetaminophen.
October 30, 2024DrugsFDA
Fresenius Kabi Compounding, LLC recalls Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, C
Hazard: cGMP violations
October 30, 2024DrugsFDA
Fresenius Kabi Compounding, LLC recalls EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canto
Hazard: cGMP violations
October 30, 2024DrugsFDA
Fresenius Kabi Compounding, LLC recalls Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Cant
Hazard: cGMP violations
October 30, 2024DrugsFDA
Fresenius Kabi Compounding, LLC recalls NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile
Hazard: cGMP violations
October 30, 2024DrugsFDA
Fresenius Kabi Compounding, LLC recalls NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile
Hazard: cGMP violations
October 30, 2024DrugsFDA
Fresenius Kabi Compounding, LLC recalls Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services,
Hazard: cGMP violations
October 30, 2024DrugsFDA
Fresenius Kabi Compounding, LLC recalls Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Service
Hazard: cGMP violations
October 30, 2024DrugsFDA
Fresenius Kabi Compounding, LLC recalls Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Service
Hazard: cGMP violations
October 30, 2024DrugsFDA
Fresenius Kabi Compounding, LLC recalls Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Service
Hazard: cGMP violations
October 30, 2024DrugsFDA
Fresenius Kabi Compounding, LLC recalls Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Service
Hazard: CGMP violations
October 23, 2024DrugsFDA
Zhejiang Jingwei Pharmaceutical Co., Ltd. recalls First Aid Antiseptic Ointment, Povidone Iodine USP 10%, Inactive Ingredients: mineral oil, petrolatum. NET Wt. 1 OZ (28.
Hazard: Incorrect/Undeclared Excipients: The inactive ingredients labeled on the product boxes and tubes are listed as "mineral oil , petrolatum ". The inactive ingredients in the actual product are polyethylene glycol 400 , polyethylene glycol 4000.
October 23, 2024DrugsFDA
Bionpharma Inc. recalls Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 0854
Hazard: Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.
October 23, 2024DrugsFDA
VIONA PHARMACEUTICALS INC recalls Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Vio
Hazard: Crystallization
October 23, 2024DrugsFDA
ACCORD HEALTHCARE, INC. recalls Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: Ac
Hazard: Failed Impurities/Degradation Specifications.
October 23, 2024DrugsFDA
Breckenridge Pharmaceutical, Inc recalls Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Di
Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
October 16, 2024DrugsFDA
123Herbals recalls Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengk
Hazard: Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.
October 9, 2024DrugsFDA
Advanced Accelerator Applications USA, Inc. recalls Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufac
Hazard: CGMP deviations
October 9, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/b
Hazard: Defective Delivery System: The dip tube is clogged causing the spray not to work.
October 9, 2024DrugsFDA
Gilead Sciences, Inc. recalls Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Fos
Hazard: Presence of Particulate Matter: Presence of glass particle.