August 28, 2024DrugsFDA
FDC Limited recalls Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64
Hazard: Defective Container: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
August 28, 2024DrugsFDA
Aurobindo Pharma USA Inc recalls Healthy Living Acetaminophen, Aspirin (NSAID) and Caffeine, tablets USP, 250 mg/250 mg/65 mg, 100-count bottles, Distrib
Hazard: Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
August 28, 2024DrugsFDA
Zeco LLC recalls HAND-I-SAN, No-Rinse Hand Sanitizer (75% Isopropyl Alcohol), packaged in a) 3.78L (1-gallon jug packaged in a case of 4
Hazard: CGMP Deviations: sterile water not used for production
August 28, 2024DrugsFDA
Zeco LLC recalls Rubbing Alcohol (70% Isopropyl Alcohol), First-Aid Antiseptic, packaged in a) 3.78L (1-gallon jug); and b) 208.19L (55-g
Hazard: CGMP Deviations: sterile water not used for production
August 28, 2024DrugsFDA
B. Braun Medical Inc recalls 0.9% Sodium Chloride Injection USP, E8000, 1000mL container, Rx only, B. Braun Medical Inc., Irvine, CA, NDC 0264-7800-0
Hazard: Presence of Particulate Matter
August 28, 2024DrugsFDA
Teva Pharmaceuticals USA, Inc recalls Testosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USA, Inc. North Wales,
Hazard: Superpotent Drug
August 28, 2024DrugsFDA
Fagron Compounding Services recalls Lidocaine HCl Injection, 2% (20mg per mL) (100 mg per 5 mL) per syringe, Rx only, Fagron Sterile Services, 8710 E. 34th
Hazard: Lack of Assurance of Sterility
August 28, 2024DrugsFDA
Hikma Pharmaceuticals USA Inc. recalls Acetaminophen Injection, 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose bags, For Intravenous Use Only, Rx Only, Man
Hazard: Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL)
August 21, 2024DrugsFDA
Taro Pharmaceuticals U.S.A., Inc. recalls Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, O
Hazard: Failed Impurities/Degradation Specifications: Out-of-specification results obtained for related impurities and slightly lower than the established level of the Hydrocortisone Assay obtained during stability testing.
August 21, 2024DrugsFDA
FDC Limited recalls Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Auran
Hazard: Defective container; yellow colored spike from cap lodged in the nozzle
August 14, 2024DrugsFDA
Granules Pharmaceuticals Inc. recalls Gabapentin Tablets, USP, 600 mg, 500-count bottles, Rx only, Manufactured by: Granules India Limited Hyderabad-500 081,
Hazard: Presence of Foreign Tablets; 3 fused tablets of Metformin ER 500 mg were found in bottle of Gabapentin Tablets
August 14, 2024DrugsFDA
A-S Medication Solutions LLC recalls Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Packaged By: A-S Medication Solutions, Libertyvill
Hazard: Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81 mg tablets.
August 14, 2024DrugsFDA
EMPOWER CLINIC SERVICES LLC recalls Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only
Hazard: Lack of Assurance of Sterility
August 14, 2024DrugsFDA
Amneal Pharmaceuticals, LLC recalls Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ
Hazard: Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
August 14, 2024DrugsFDA
Novel Laboratories, Inc. d.b.a Lupin Somerset recalls PEG-3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, and Ascorbic Acid for Oral Solution 100
Hazard: Defective container: potential for non-sealed pouches which can lead to product leakage.
August 14, 2024DrugsFDA
Granules Consumer Health Inc. recalls Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HD
Hazard: Label mix-up: Carton incorrectly labeled.
August 14, 2024DrugsFDA
MAIN PRODUCTS INC recalls Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
Hazard: Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
August 14, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Lab
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
August 7, 2024DrugsFDA
Eugia US LLC recalls Progesterone Injection, USP, 500 mg per 10 mL (50mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Mfd. in India for: Eugia US
Hazard: Presence of Particulate Matter: Complaint received of a glass particle in the vial.
August 7, 2024DrugsFDA
FDC Limited recalls Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 693
Hazard: Defective container: unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
August 7, 2024DrugsFDA
Endo Pharmaceuticals, Inc. recalls Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125mg, 60 tablets per carton (10 blister cards containing 6 table
Hazard: Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
August 7, 2024DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez,
Hazard: CGMP Deviations
August 7, 2024DrugsFDA
SoloVital recalls Umary Acido Hialuronico, Suplemento Alimenticio, 850 mg caplets, packaged in 30-count bottles.
Hazard: Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
August 7, 2024DrugsFDA
Amerisource Health Services LLC recalls Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-count bottle ( NDC 68001-396-00), b) 500-co
Hazard: Failed Dissolution Specifications
July 31, 2024DrugsFDA
Washington Homeopathic Products, Inc. recalls Complete 30C/200C Homeopathic Kit, Contains: One hundred 1/2 dram vials of homeopathic medicines, Washington Homeopathic
Hazard: Labeling: Label Mix-up: Some bottles of Ferrum Phosphoricum 200C were incorrectly labeled as Ferrum Metallicum 200C.
July 31, 2024DrugsFDA
Zydus Pharmaceuticals (USA) Inc recalls Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and
Hazard: Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
July 31, 2024DrugsFDA
GLOBAL WIDGET LLC recalls Hemp Bombs CBD Pain Freeze (menthol 4%), 1000mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL
Hazard: Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
July 31, 2024DrugsFDA
GLOBAL WIDGET LLC recalls Hemp Bombs CBD Pain Freeze (menthol 4%), 400mg, 4 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL
Hazard: Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
July 31, 2024DrugsFDA
GLOBAL WIDGET LLC recalls Nature's Script CBD Cryotherapy Pain Relief Roll on (menthol 4%) 200mg, 1 oz bottles, Distributed by: Global Widget 8419
Hazard: Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
July 31, 2024DrugsFDA
GLOBAL WIDGET LLC recalls Hemp Bombs CBD Pain Freeze (menthol 4%), 100mg, 1 oz bottles, Distributed by: Global Widget 8419 Sunstate St, Tampa FL 3
Hazard: Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.