March 20, 2019DrugsFDA
King Bio Inc. recalls Dr. King's Natural Medicine Homeopathic Colds & Flu Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
Hazard: Microbial contamination
March 20, 2019DrugsFDA
King Bio Inc. recalls Dr. King's Natural Medicine Homeopathic Skin Irritations & Itch Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr
Hazard: Microbial contamination
March 20, 2019DrugsFDA
King Bio Inc. recalls Dr. King's Natural Medicine Homeopathic Migraine Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
Hazard: Microbial contamination
March 20, 2019DrugsFDA
King Bio Inc. recalls Dr. King's Natural Medicine Homeopathic Regional Allergies Southwestern U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Wests
Hazard: Microbial contamination
March 20, 2019DrugsFDA
King Bio Inc. recalls Dr. King's Natural Medicine Homeopathic Regional Allergies Great Lakes U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westsi
Hazard: Microbial contamination
March 20, 2019DrugsFDA
King Bio Inc. recalls Dr. King's Natural Medicine Homeopathic Regional Allergies Desert U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr
Hazard: Microbial contamination
March 20, 2019DrugsFDA
King Bio Inc. recalls Dr. King's Natural Medicine Homeopathic Regional Allergies Plains U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr
Hazard: Microbial contamination
March 20, 2019DrugsFDA
King Bio Inc. recalls Dr. King's Natural Medicine Homeopathic Heartburn Reliever, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville,
Hazard: Microbial contamination
March 20, 2019DrugsFDA
King Bio Inc. recalls Dr. King's Natural Medicine Homeopathic Heart Regularity, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, N
Hazard: Microbial contamination
March 20, 2019DrugsFDA
King Bio Inc. recalls Dr. King's Natural Medicine Homeopathic Regional Allergies Southern U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Hazard: Microbial contamination
March 20, 2019DrugsFDA
King Bio Inc. recalls Dr. King's Natural Medicine Homeopathic Bladder Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC
Hazard: Microbial contamination
March 20, 2019DrugsFDA
King Bio Inc. recalls Dr. King's Natural Medicine Homeopathic Regional Allergies Pacific U.S. 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr
Hazard: Microbial contamination
March 20, 2019DrugsFDA
King Bio Inc. recalls Dr. King's Natural Medicine Homeopathic Menstrual Cramps & Irregularities 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside
Hazard: Microbial contamination
March 20, 2019DrugsFDA
King Bio Inc. recalls Dr. King's Natural Medicine Homeopathic Cold Sores & Herpes, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville
Hazard: Microbial contamination
March 20, 2019DrugsFDA
King Bio Inc. recalls Dr. King's Natural Medicine Homeopathic Regional Allergies Rocky Mtns. U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westsi
Hazard: Microbial contamination
March 20, 2019DrugsFDA
King Bio Inc. recalls Dr. King's Natural Medicine Homeopathic Regional Allergies Northeastern U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3 Wests
Hazard: Microbial contamination
March 20, 2019DrugsFDA
King Bio Inc. recalls Dr. King's Natural Medicine Homeopathic Male Libido, 2 fl. oz. (59 mL), King Bio, Inc. 3 Westside Dr. Asheville, NC 2880
Hazard: Microbial contamination
March 20, 2019DrugsFDA
King Bio Inc. recalls Dr. King's Lymph Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806, UPC 357955506324, NDC 579
Hazard: Microbial contamination
March 20, 2019DrugsFDA
King Bio Inc. recalls Dr. King's aquaflora Candida High Potency, 8 fl. oz. (236 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806 USA,
Hazard: Microbial contamination
March 13, 2019DrugsFDA
Ascend Laboratories LLC recalls Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mu
Hazard: Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
March 13, 2019DrugsFDA
Petra Hygienic Systems Int Ltd recalls ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4 litres/1.1 US Gallon bottles, packaged in 4 x 4 Litres
Hazard: Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter consumer antiseptic/antibacterial wash products.
March 13, 2019DrugsFDA
Apotex Inc. recalls Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as
Hazard: Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
March 13, 2019DrugsFDA
Todd Holiday dba Sunstone Organics recalls Maeng Da Kratom, packaged in a) 20 count capsules (UPC 00859667007149), b) 60 count capsules (UPC 00859667007156), c) 15
Hazard: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
March 13, 2019DrugsFDA
Todd Holiday dba Sunstone Organics recalls White Vein Kratom, packaged in a) 20 count capsules (UPC 00859667007347), b) 60 count capsules (UPC 00859667007354), c)
Hazard: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
March 13, 2019DrugsFDA
Todd Holiday dba Sunstone Organics recalls White Vein Kratom, packaged in a) 25 gram powder (UPC 00859667007316), b) 50 gram powder (UPC 00859667007323), c) 100 gr
Hazard: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
March 13, 2019DrugsFDA
Todd Holiday dba Sunstone Organics recalls Maeng Da Kratom, packaged in a) 25 gram powder (UPC 00859667007118), b) 50 gram powder (UPC 00859667007125), c) 100 gram
Hazard: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella.
March 13, 2019DrugsFDA
Vi-Jon, Inc. recalls Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral Debriding Agent 32 Fl. Oz. (1 QT) 946 mL bottle, Distri
Hazard: Cross Contamination: Presence of IPA in finished product.
March 13, 2019DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC 59
Hazard: Failed Dissolution Specifications; 9-monthstability timepoint
March 13, 2019DrugsFDA
Leiter's Enterprises, Inc. recalls Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use Only
Hazard: Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
March 6, 2019DrugsFDA
Lupin Pharmaceuticals Inc. recalls Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 7
Hazard: Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.