Drug recalls
Enforcement reports from the FDA's weekly recall database. Recalls are classified by the health hazard the defect presents: Class I where exposure is reasonably likely to cause serious harm or death, Class II where it may cause temporary or reversible harm, and Class III where it is unlikely to cause harm.
17,975 records · source: openFDA Enforcement
All classes 17,975 Class II 14,511 Class I 1,747 Class III 1,715 Not Yet Classified 2
| Class | Reported | Product | Reason | Firm | Status |
|---|---|---|---|---|---|
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Odor Freee..., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Colds & Flu Immune, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Stress Control, 59 mL, (liquid/liquide), DIN-HM 80041740 UPC… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Wart Freee, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Lymph Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Allergies Plains U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Fever Reliever Immune, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Allergies Rocky Mtns. U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Additive & Preservative Detox, 2 fl. oz. (59 mL),… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Arthritis & Joint Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Children's Appetite Enhancer Children High Potency Homeopathic… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Bactero Reliever, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Stye Relief, 2 fl. oz. (59 mL),King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Religious Issues, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Sinus Relief High Potency Homeopathic Formula, 2 fl oz (59 mL),… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Teeth & Gums Formula, 2 fl. oz. (59 mL), King… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Migraine Relief, 2 fl. oz. (59 mL), King Bio,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx ChemoClenz, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx ICV Clenz Cleansing & Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Baby Colic Relief Homeopathic, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Blood & Kidney Detox, 2 fl. oz. (59 mL), King… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Female Libido, 2 fl. oz. (59 mL), King Bio, Inc.,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Self-Pity, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Wart Freee..., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Eye Stress, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Fragrance & Phenolic Allergy Relief, 2 fl. oz.… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Mood Changes, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Bladder Formula Urinary, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Dairy Intolerances, 2 fl. oz. (59 mL), King Bio,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Head Colds Relief, 2 fl. oz. (59 mL), King Bio,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Cooling Acute Pain Relief Pure Homeopathic Cream, 3 oz. (85… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Personality Changes, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | NET Remedies #7 Homeopathic Preparation, Oral Liquid, 57 mL, Manufacturer: King Bio Inc.… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Gout Symptom Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Melancholic Homeopathic, 2 fl oz (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Allergies Southwest U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Adrenal Burnout Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Restless Mind, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | NET Remedies #3 (Blue Label) Homeopathic Preparation, Oral Liquid, 57 mL, Manufacturer:… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Menopause Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Restless Leg Syndrome, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Calcium Metabolizer, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Anti-Aging & Wrinkles for Men, 2 fl. oz. (59 mL),… | Microbial contamination | King Bio Inc. | Terminated |
| Class III | March 20, 2019 | Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per… | Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing. | Boehringer Ingelheim Pharmaceuticals, Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Self-Abuse, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx M3 Metabolic Mineral Modulator, 2 fl. oz. (59 mL), King Bio, Inc.,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx CS-Stomach, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Aller-Detox: Cosmetics & Household, 2 fl. oz. (59 mL), King Bio,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic ShinglePlex, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Advanced First Aid, 2 fl. oz. (59 mL), King Bio,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Total Body Detox, 2 fl. oz. (59 mL), King Bio,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Hair & Nails Formula, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Bladder Formula, 2 fl. oz. (59 mL), King Bio,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Head Colds Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Stress Control, 2 fl. oz. (59 mL), King Bio,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | NET Remedies #4 Homeopathic Preparation, Oral Liquid, 57 mL, Manufacturer: King Bio Inc.… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Tinnitus Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | NET Remedies #10 (Maroon Label) Homeopathic Preparation, Oral Liquid, 57 mL,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx ShinglePlex Skin, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Safecare+ Northeast Regional Allergies Non-Drowsy Homeopathic Taste-Free, Oral Spray, 1… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx First Aid for Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Foul Bowel, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Water Chemical Detox, 2 fl. oz. (59 mL), King… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | NET Remedies #7 Flora Plus Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4207-2 | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Allergies Great Lakes U.S., 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Mental Alertness For Seniors, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Aquaflora Candida High Potency 9 Multi-Strain Candida… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Athlete's Foot Fighter, 2 fl. oz. (59 mL), King… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Insecurity, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Complaining, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Acne Clear, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Alcoholism Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic CataClenz Eye Relief, 2 fl. oz. (59 mL), King… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Sinus Relief, 2 fl. oz. (59 mL), King Bio, Inc.,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Regional Allergies Canadian Prairies, 59 mL (liquid/liquide),… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Heartburn Reliever, 2 fl. oz. (59 mL), King Bio,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Snore Control, 2 fl. oz. (59 mL), King Bio, Inc.,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Allergies: Fruits & Vegetables, 2 fl. oz. (59 mL), King Bio, Inc.,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Allergies: Dairy, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Hemorrhoid Relief, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx GallPlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | NET Remedies #1 (Yellow Label) Homeopathic Preparation, Oral Liquid, 57 mL, Manufacturer:… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Good Mood Enhancer Homeopathic, 2 fl oz (59 mL), King Bio,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Warming Arthritic Pain & Joint Relief Homeopathic Cream, Net… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Tummy Aches Children High Potency Homeopathic Formula for… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Prejudiced, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Envious, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Arthritis Pain & Joint Relief Soulagement De La Douleur Arthritique et… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Back, Muscle & Joint Relief, 2 fl. oz. (59 mL),… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Male Libido, 2 fl. oz. (59 mL), King Bio, Inc. 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Eye Stress, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | NET Remedies #9 ER 911 Homeopathic Preparation, Oral Liquid, 57 mL, NDC 57955-4209-2 | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Kids Tummy Aches Homeopathic, 2 fl. oz. (59 mL), King Bio,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Smoke Control, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | NET Remedies #10 Scars-Adhesions Homeopathic Preparation, Oral Liquid, 57 mL, NDC… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Regional Allergies Plains U.S., 2 fl. oz. (59… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx LymePlex, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Hair & Nails Formula, 2 fl. oz. (59 mL), King… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx CS-Pain Reliever, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Migraine Freee..., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Easily Angered, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Intense Anxiety Mind & Body, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx ParaClenz, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Safecare+ Southeast Regional Allergies Homeopathic Non-Drowsy Taste Free, Oral Spray, 1… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Eczema Symptom Relief Homeopathic Topical Lotion, 3 oz. (85… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | NET Remedies #24 Homeopathic Preparation, Oral Liquid, 57 mL, Manufacturer: King Bio Inc.… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Bone Strengthener, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Multi-Strain Flu Relief, 59 mL, (liquid/liquid), DIN-HM… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | NET Remedies #24 Day & Night Vitals Homeopathic Preparation, Oral Liquid, 57 mL, NDC… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Regional Allergies Rocky Mtns. U.S., 2 fl. oz.… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx FertiCare, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Constitutional Enhancer, 2 fl. oz. (59 mL), King… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Scar Freee, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx CataCure, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Allergy & Red Eye Relief, 2 fl. oz. (59 mL), King… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx TUBR Miasm, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Bed Wetting Prevention Children High Potency Homeopathic Formula… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Female Discomforts, 2 fl. oz. (59 mL), King Bio,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Kids Aquaflora Candida Multi-Strain Formula, 118 mL (liquid),… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Climate Adaptation Hot & Dry, 2 fl. oz. (59 mL),… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Allergies: Eggs & Meats, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Total Body Detox Cleansing & Detox, 2 fl. oz. (59 mL), King Bio,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic TMJ/Jaw Formula, 2 fl. oz. (59 mL), King Bio,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Hyperactive High Potency Homeopathic Formula, 2 fl oz (59 mL),… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine for kids! Chicken Pox Symptom Relief Homeopathic, 2 fl. oz.… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx CS-Skin, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… | Microbial contamination | King Bio Inc. | Terminated |
| Class II | March 20, 2019 | Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only,… | Failed Content Uniformity Specifications: The product is out of specification for blend uniformity. | Macleods Pharma Usa Inc | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Urinary Tract Infections, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Chicken Pox Symptom Relief Children High Potency Homeopathic… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Stye Freee..., 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Good Mood Enhancer, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | NET Remedies #25 (Yellow, White and Purple Label) Homeopathic Preparation, Oral Liquid,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Paralixer, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic Cough Relief, 2 fl. oz. (59 mL), King Bio, Inc.,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Homeopathic EMF Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Sleep Aid, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Psoriasis Symptom Relief Homeopathic Topical Lotion, 3 oz.… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Kids Stress & Anxiety Homeopathic, 2 fl. oz. (59 mL), King… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Wounds Recovery, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Cough Control, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's Natural Medicine Children's Appetite Enhancer for kids! Homeopathic, 2 fl. oz.… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Repressed Sexual Issues Mind & Body, 2 fl. oz. (59 mL), King Bio,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Breast Cyst & Discomforts, 2 fl. oz. (59 mL), King Bio, Inc., 3… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Gossipy, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Drive,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Allergies Pacific U.S. Homeopathic, 2 fl oz (59 mL), King Bio,… | Microbial contamination | King Bio Inc. | Terminated |
| Class III | March 20, 2019 | Oxybutynin Chloride Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01)… | Failed Dissolution Specifications | AVKARE Inc. | Terminated |
| Class I | March 20, 2019 | Dr. King's SafeCare Rx Back, Neck, Muscle & Joint Injuries, 2 fl. oz. (59 mL), King Bio,… | Microbial contamination | King Bio Inc. | Terminated |
| Class I | March 13, 2019 | Maeng Da Kratom, packaged in a) 20 count capsules (UPC 00859667007149), b) 60 count… | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. | Todd Holiday dba Sunstone Organics | Terminated |
| Class III | March 13, 2019 | BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC… | Failed Dissolution Specifications; 9-monthstability timepoint | Jubilant Cadista Pharmaceuticals, Inc. | Terminated |
| Class II | March 13, 2019 | Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial,… | Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium… | Leiter's Enterprises, Inc. | Terminated |
| Class II | March 13, 2019 | Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit… | Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement. | Apotex Inc. | Completed |
| Class I | March 13, 2019 | White Vein Kratom, packaged in a) 25 gram powder (UPC 00859667007316), b) 50 gram powder… | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. | Todd Holiday dba Sunstone Organics | Terminated |
| Class I | March 13, 2019 | White Vein Kratom, packaged in a) 20 count capsules (UPC 00859667007347), b) 60 count… | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. | Todd Holiday dba Sunstone Organics | Terminated |
| Class III | March 13, 2019 | ATHLETICARE Anti-Bacterial Hand Soap AC 550 (triclosan), 0.25%, 4 litres/1.1 US Gallon… | Does Not Meet Monograph: product contains, triclosan, an ingredient that can no longer be contained in over-the-counter… | Petra Hygienic Systems Int Ltd | Terminated |
| Class I | March 13, 2019 | Maeng Da Kratom, packaged in a) 25 gram powder (UPC 00859667007118), b) 50 gram powder… | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS: Analysis of samples were positive for Salmonella. | Todd Holiday dba Sunstone Organics | Terminated |
| Class II | March 13, 2019 | Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral Debriding Agent 32 Fl.… | Cross Contamination: Presence of IPA in finished product. | Vi-Jon, Inc. | Terminated |
| Class II | March 13, 2019 | Tamsulosin Hydrochloride Tamsulosin Hydrochloride Capsules, USP, 0.4 mg, 500-count bottles, Rx Only, Manufactured… | Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing. | Ascend Laboratories LLC | Terminated |
| Class III | March 6, 2019 | MOXIFLOXACIN Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin… | Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high… | Lupin Pharmaceuticals Inc. | Terminated |
| Class III | February 27, 2019 | Oxytocin 10 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable… | Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label. | Advanced Pharma Inc. | Terminated |
| Class II | February 27, 2019 | Fentanyl in 0.9% Sodium Chloride QS 0.5 mL, 5 mcg/0.5 mL with up to 0.1 mL of overfill… | Labeling: Incorrect expiration date. | Advanced Pharma Inc. | Terminated |
| Class II | February 27, 2019 | tubby todd Bath Co, 100% NATURAL DREAM CREAM, Shea Butter and Mint, 3.5 FL OZ 99G,… | Microbial Contamination of Non-Sterile Products: Consumer complaint and subsequent testing found lot to be out of… | Mariposa Labs LLC | Terminated |
| Class III | February 27, 2019 | Diltiazem HCl Extended-Release Capsules, USP 180mg, Packaged in a) 100-count bottles (NDC… | Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability… | Mylan Pharmaceuticals Inc. | Terminated |
| Class II | February 27, 2019 | Ephedrine Sulfate, 50 mg/10 mL, 10 mL Single Use Syringe, Rx only, US Compounding… | Lack of assurance of sterility. | US Compounding Inc | Terminated |
| Class III | February 27, 2019 | Oxytocin 20 Units added to NS 1000 mL (oxytocin and 0.9% Sodium Chloride) Injectable… | Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label. | Advanced Pharma Inc. | Terminated |
| Class III | February 27, 2019 | Oxytocin 30 Units added to NS 500 mL (oxytocin and 0.9% Sodium Chloride) Injectable… | Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label. | Advanced Pharma Inc. | Terminated |
| Class III | February 27, 2019 | Temozolomide Capsules, 5 mg, packaged in a) 5-count bottle (NDC 43975-252-05) b) 14-count… | Failed dissolution specifications | Amerigen Pharmaceuticals Inc. | Terminated |
| Class II | February 27, 2019 | Moisturizing Lubricant Eye Drops, 0.25% Sodium Carboxymethylcellulose, 0.5 Fl OZ (15mL)… | Failed Stability Specification: out of specification results for Sodium Perborate | Akorn Inc | Terminated |
| Class III | February 27, 2019 | Clobetasol Propionate Emollient Cream 0.05%, a) 30 gram (NDC 50383-270-30) and b) 60 gram… | Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study. | Akorn Inc | Terminated |
| Class II | February 27, 2019 | 0.9% Sodium Chloride Injection, USP 1000 mL flexible container, Rx only, Hospira, Inc.,… | CGMP Deviations | ICU Medical Inc | Terminated |
| Class II | February 27, 2019 | LOSARTAN POTASSIUM TABLETS, USP, 100 mg, a) 30-count (NDC: 13668-115-30), b) 90-count… | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to… | Torrent Pharma Inc. | Ongoing |
| Class II | February 27, 2019 | LOSARTAN POTASSIUM TABLETS, USP, 50 mg, a) 30-count bottle (NDC: 13668-409-30), b)… | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to… | Torrent Pharma Inc. | Ongoing |
| Class III | February 27, 2019 | Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories,… | Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error. | ACP Nimble Buyer, Inc. | Terminated |
| Class II | February 27, 2019 | LOSARTAN POTASSIUM TABLETS, USP, 25 mg, 90-count bottle (NDC: 13668-113-90), Rx only,… | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to… | Torrent Pharma Inc. | Ongoing |
| Class II | February 27, 2019 | LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP 50 mg/12.5 mg, a) 90-count bottle… | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to… | Torrent Pharma Inc. | Ongoing |
| Class II | February 27, 2019 | LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count… | CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to… | Torrent Pharma Inc. | Ongoing |
| Class III | February 27, 2019 | ciclopirox Ciclopirox shampoo 1%,120 mL bottle, Rx only, Manufactured By Perrigo Bronx, NY 10457… | Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing. | Perrigo New York, Inc. | Terminated |
| Class III | February 27, 2019 | Lovastatin Lovastatin Tablets USP, 40 mg, packaged in a) 60-count (NDC 68180-469-07 and b) 100-count… | CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual… | Lupin Pharmaceuticals Inc. | Terminated |
| Class II | February 27, 2019 | Divalproex sodium Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only,… | Failed Dissolution Specifications: Out of specification results observed for high dissolution. | Dr. Reddy's Laboratories, Inc. | Terminated |
| Class II | February 20, 2019 | Zinc Sulfate,10mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | ICB-Complex,… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | IGF-1-LR3, 3 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only,… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Myer's Cocktail, Pyridoxine/Dexpanthenol/Calcium Gluconate/Niacinamide/Vit B6/Vit… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%, Combo Drops 3 mL, Rx Only,… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | MAGnesium 2gm sulfate, added to D5W 50 mL, Volume: 54 mL, Sterile single use bag,… | Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that,… | Avella of Deer Valley, Inc. Store 38 | Terminated |
| Class II | February 20, 2019 | Zinc Sulfate, 5mg/mL injection, 10ml vial, Rx Only, Promise Pharmacy Compounding… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops 3 mL, Rx Only,… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Sermorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25… | Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. | Tris Pharma Inc. | Terminated |
| Class II | February 20, 2019 | Sermorelin/GHRP2/GHRP6 6mg/3mg/3mg injection, Rx Only, Promise Pharmacy Compounding… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Glycyrrhizic Acid, 8mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Vitamin B Complex, Dexpanthenol/Leucine/Niacinamide/Pyridoxine/Riboflavin/Thiamine 2… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Lysine HCl, 100 mg/mL injection, 10ml, Rx Only, Promise Pharmacy Compounding Specialists… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Multi Trace, Zinc/Copper/Manganese/Selenium 5mg/1mg/0.5mg/60mcg/ml, injection 30 mL, Rx… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Ipamorelin, 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Epithalon, 15mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution, 1%/0.5%/0.09%, Combo… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | MAGnesium 1gm sulfate, added to D5W 50 mL, Volume 52 mL, sterile single use bag,… | Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that,… | Avella of Deer Valley, Inc. Store 38 | Terminated |
| Class II | February 20, 2019 | Acetylcysteine Ophthalmic Solution, 100mg/ml, 10%, Rx only, Promise Pharmacy Compounding… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | LET Gel 4% (Lidocaine HCl 4% + EPINEPHrine HCl 0.05% + Tetracaine HCl 0.5%), 3mL Single… | Labeling: Incorrect or Missing Lot and/or Exp Date: Labels are missing lot and expiration date and are printed as Lot#… | US Compounding Inc | Terminated |
| Class II | February 20, 2019 | Ipamorelin, 15mg, injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Pyridoxine HCl, 100 mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Dexpanthenol, 250mg/mL Injection, 10ml vial, Rx Only, Promise Pharmacy Compounding… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Bremelanotide (PT 141), 20mg injection, Rx Only, Promise Pharmacy Compounding Specialists… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Nicotinamide Adenine Dinucleotide, 0.5 mg, injection, 10mL vial, Rx Only, Promise… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Niacinamide injection, 100mg/mL, 5mL vial, Rx Only, Promise Pharmacy Compounding… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Thymosin Beta-4, 15 mg Injection, Rx Only, Promise Pharmacy Compounding Specialists 31818… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Sermorelin Theanine/GHRP2, 15 mg/75 mg/5.4 mg injection, Rx Only, Promise Pharmacy… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class III | February 20, 2019 | Esomeprazole Magnesium Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC… | Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets. | Dr. Reddy's Laboratories, Inc. | Terminated |
| Class II | February 20, 2019 | Folic Acid, 5mg/ml injection, 10ml vial, Rx Only, Promise Pharmacy Compounding… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Melanotan II, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25… | Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. | Tris Pharma Inc. | Terminated |
| Class III | February 20, 2019 | COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10… | Failed Stability Specifications: out of specification results for opalescence at 7 month stability study. | Akorn Inc | Terminated |
| Class II | February 20, 2019 | Trim Complete, Methlonine/Inositol/Choline/Thiamine/Riboflavin/Niacinamide… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25… | Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled. | Tris Pharma Inc. | Terminated |
| Class II | February 20, 2019 | Glutathione Injection, 200 mg/mL, 10 mL, Rx Only, Promise Pharmacy Compounding… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Vitamin D3 50,000iu/mL, injection 5 mL, Rx Only, Promise Pharmacy Compounding Specialists… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Trim Calm, GABA/Magnesium/Taurine/Theanine, 50mg/50mg/50mg/50mg/ml, 10mL vial, Rx Only,… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | HCG, Human chorionic gonadotropin 5,000 units, injection, Rx Only, Promise Pharmacy… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Methylcobalamin lyophilized, 10,000 mcg Injection, Rx Only, Promise Pharmacy Compounding… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Leucine/Isoleucine/Valine injection, 10mg/10mg/5mg/mL/mL, 10mL vial, Rx Only, Promise… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | BPC 157, 10mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | MIC B12+L-Carnitine+Chromium injection, Methionine Inositol Choline… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Labetalol 20mg, HCL, USP Injectable Solution, 20mg/4mL (5 mg per mL), 4mL single use… | Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that,… | Avella of Deer Valley, Inc. Store 38 | Terminated |
| Class II | February 20, 2019 | Amino Blend Injection, Ornithine/Arginine/Lysine/Lidocaine 75 mg/75 mg/75 mg/10 mg/mL 10… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Ipamorelin+Sermorelin, 15mg/15mg, injection, Rx Only, Promise Pharmacy Compounding… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Ascorbic Acid, Compounded-Tapioca, 450 mg/mL Injection, 50 mL, Rx Only, Promise Pharmacy… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%, Combo… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Procaine HCl, 2% injection, 10ml vial, Rx Only, Promise Pharmacy Compounding Specialists… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Sermorelin/GHRP2/GHRP6, 9 mg/9 mg/9 mg injection, Rx Only, Promise Pharmacy Compounding… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Sermorelin 9 mg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US Hwy… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | HCG, Human chorionic gonadotropin 11,000 units, injection, Rx Only, Promise Pharmacy… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class III | February 20, 2019 | clobetasol propionate Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for:… | Defective Container; complaints of leakage. | Oxalis Labs | Terminated |
| Class II | February 20, 2019 | MAGnesium 2 gm sulfate, added to NS 50 mL, Sterile single use bag, 54 mL, Compounded by… | Labeling: Incorrect or Missing Lot and/or Exp Date:The product labels contain a Two-Dimensional ( 2D ) barcode that,… | Avella of Deer Valley, Inc. Store 38 | Terminated |
| Class II | February 20, 2019 | CIDOFOVIR DIHYDRATE, (Non-Sterile, For Manufacturing Use), 10g, Rx only, ALP PHARM… | CGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. | LGM Pharma LLC | Terminated |
| Class II | February 20, 2019 | Ipamorelin+Modified GRF 1-29, 9 mg/5mg injection, Rx Only, Promise Pharmacy Compounding… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Prednisolone and Gatifloxacin and Bromfenac, Ophthalmic Solution, 1%/0.5%/0.09%, Combo… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Folic Acid, Injection, 10 mg/mL, 10mL vial, Rx Only, Promise Pharmacy Compounding… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | HCG, Human chorionic gonadotropin 2,000 units, injection, Rx Only, Promise Pharmacy… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | Methylcobalamin lyophilized 50,000 mcg Injection, Rx Only, Promise Pharmacy Compounding… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class II | February 20, 2019 | IGF-1 LR3, 620 mcg injection, Rx Only, Promise Pharmacy Compounding Specialists 31818 US… | Lack of sterility assurance. | Promise Pharmacy, LLC | Terminated |
| Class III | February 20, 2019 | Diltiazem HCl CD capsules, 360 mg, 90-count bottles, Rx Only, Manufactured for: Oceanside… | Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug… | Valeant Pharmaceuticals North America LLC | Terminated |
| Class III | February 20, 2019 | Cardizem CD Cardizem CD (diltiazem HCl) capsules, 180 mg, packaged in a) 30-count bottles (NDC… | Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug… | Valeant Pharmaceuticals North America LLC | Terminated |
| Class III | February 20, 2019 | Cardizem CD Cardizem CD (diltiazem HCl) capsules, 120 mg, packaged in a) 30-count bottles (NDC… | Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug… | Valeant Pharmaceuticals North America LLC | Terminated |
| Class III | February 20, 2019 | MOXIFLOXACIN Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL dropper bottle, Rx Only, Manufactured… | Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month… | Lupin Pharmaceuticals Inc. | Terminated |
| Class III | February 20, 2019 | Cardizem CD Cardizem CD (diltiazem HCl) capsules, 240 mg, packaged in a) 30-count bottles (NDC… | Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug… | Valeant Pharmaceuticals North America LLC | Terminated |
| Class I | February 20, 2019 | Levetiracetam Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For… | Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly… | Dr. Reddy's Laboratories, Inc. | Terminated |
| Class III | February 20, 2019 | Cardizem CD Cardizem CD (diltiazem HCl) capsules, 300 mg, packaged in a) 30-count bottles (NDC… | Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug… | Valeant Pharmaceuticals North America LLC | Terminated |
| Class I | February 13, 2019 | the silver bullet 10x Capsules, 725 mg each (proprietary blend of: Mucuna Pruriens… | Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with undeclared sildenafil and tadalafil | Natures Rx | Terminated |
| Class III | February 13, 2019 | Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5… | Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total… | Lupin Pharmaceuticals Inc. | Terminated |