Summary

Company Announcement Date: August 22, 2018 FDA Publish Date: August 24, 2018 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination Company Name: King Bio Brand Name: Brand Name(s) KB, DK, more Product Description: Product Description Homeopathic products

Company Announcement

King Bio is voluntarily recalling the below products to the consumer level.

A small percentage of our products produced between 08/01/2015 and 08/01/2018 have tested positive for microbial contamination. Out of an abundance of caution, we are recalling the products and lot numbers below.

Administration or use of drug products with microbial contamination, could potentially result in increased infections that may require medical intervention, and could result in infections that could be life threatening to certain individuals. King Bio has not received reports of injury or illness to date.

Description Packaging Intended use UDF_UPC LOT LOT LOT LOT LOT DK Attention

& Learning Enh. 2 oz. bottle A natural aid for: slow or difficult comprehension, overexcitement, writing wrong words or syllables, oversensitivity, forgetfulness, lack of assertiveness, shyness, apprehension. 357955501527 050216G 070816C 092617F Chicken Pox Symptom Relief 2 oz. bottle For temporary relief of multiple symptoms including intense itching from skin rash and vesicles (blisters), headache, fever, swollen glands, cough, sore throat, tummy ache, irritability, restlessness, fatigue, and loss of appetite. 357955602521 021216K 062716D Children's Appetite & Weight 2 oz. bottle For relief of hunger – appetite suppression to control that empty feeling in the stomach otherwise relieved by eating. For weight control – maximizes the metabolism to eliminate cravings and metabolic tendencies to gain weight. It promotes healthy weight loss and supported the emotional balance and motivation necessary to reach and maintain a healthy weight. 357955551720 080916M 091316D 050516E 072516E Children's Appetite Enhance 2 oz. bottle a natural aid for: loss of appetite, no desire to eat, aversion to food, and inability to bear the sight or smell of food. 357955531821 020117F 060216E 080916B 092415F Children's Cough Relief 2 oz. bottle For temporary relief of cough symptoms: dry or hoarse cough, hacking, barking, tickling or spasmodic cough, croupy cough and throat irritation, and excess mucus. 357955514527 021216J 030916T 092815E Children's Fever Reliever 2 oz. bottle For symptomatic relief of: fever, sweats, chills, aches. 357955515920 021216H 052616H 102815C 120816A Children's Growth & Development 2 oz. bottle A natural aid for: impaired growth, weak muscular growth, loss of appetite, poor mineral absorption, nervousness, lack of focus, mental weakness, loss of confidence. 357955514220 050516E 072516E DK Newborn Tonic 2 oz. bottle For temporary relief of symptoms: skin rashes, discoloration, minor skin problems, pimples, restlessness. If symptoms persist for more than 7 days, consult your physician. 357955511427 063016K 112315F DK Nosebleed Relief 2 oz. bottle For temporary relief of: nosebleeds commonly associated with irritations or strains, colds, coughing, sneezing or menses. Also for nighttime nosebleeds. 357955514022 050516H 080916J TonsilPlex 2 oz. bottle For temporary relief of: sore throat, inflammation, swollen glands, difficulty swallowing, associated fever, redness and burning, sensation of a lump in the throat, congestion, and mucus. 357955501725 041416K 061616D Children's Ear Relief Formula 2 oz. bottle For temporary relief of symptoms: clogged sensation, noises in ear, accumulation of ear wax. 357955531524 072516G 112315B 050216P DK Teething 2 oz. bottle For temporary relief of symptoms: teething pain, irritated gums, delayed teething, fever-like disturbances, restlessness, heavy salivation and drooling, irritability, desire to be held constantly. 357955501824 020717B 110716C 080317D 111617E 020118F DK Colic Relief 2 oz. bottle For temporary relief of: abdominal discomfort, pressure, and distention, spitting up, gas and bloating, cramping, pain, irritability, desire to be held constantly, weak digestion, restless sleep. 357955515821 092017A 020118H Tummy Aches 2 oz. bottle For temporary relief of symptoms: upset stomach, nausea, vomiting, aversion to food, stomach cramps, hollow, empty, or sinking feeling, pale or flushed skin, headaches. 357955514626 050516D 072216Q 021918B Kids Multi- Strain Flu Relief 2 oz. bottle Temporarily relieves flu-like symptoms: fever, body aches, chills, night sweats, irritability, restlessness, flushed face, burning in eyes, nausea, vomiting, headache, diarrhea, sneezing, nasal congestion, sore throat, swollen tonsils, cough, and fatigue. 357955042228 071316A 071316A 111015B 112015A Kids Stress & Anxiety 2 oz. bottle For temporary relief of symptoms: minor anxiety, fear, irritability, nervousness, minor mood swings, restlessness, stage fright, nervous stomach, oversensitivity. 357955042327 070516E 081016G Kids Sleep Aid 2 oz. bottle For temporary relief of symptoms due to occasional sleeplessness: restlessness, nervousness, exhaustion, excitability, inability to fall or stay asleep, worry. 357955042426 063016D 081016F Kids Bed Wetting (NP) 2 oz. bottle For relief of involuntary urination during sleep, urinary disturbances, and restless sleep. 357955501220 111717C 101615B Kids Candida 4 oz 4 oz. bottle For symptomatic relief of Candida yeast overgrowth: thrush, cradle cap, pimples, tummy aches, constipation, craves sweets and odd foods, lethargy, lack of assertiveness, forgetfulness, spacey, poor concentration, irritable, moody, weak muscles, itchy skin and head, overexcitement and fearfulness. 357955332244 011416G 011917R 081016E 092815AA 041518H Kids Attention & Learning (SCRX) 2 oz. bottle A natural aid for: slow or difficult comprehension, overexcitement, writing wrong words or syllables, oversensitivity, forgetfulness, lack of assertiveness, shyness, apprehension. 357955001522 121617A 032316C 091216A Bed Wetting Prevention (SCRX) 2 oz. bottle For relief of involuntary urination during sleep, urinary disturbances, and restless sleep. 357955001225 102216B Chicken Pox Symptom Relief (SCRX) 2 oz. bottle For temporary relief of multiple symptoms including intense

itching from skin rash and vesicles (blisters), headache, fever, swollen glands, cough, sore throat, tummy ache, irritability, restlessness, fatigue, and loss of appetite. 357955782520 042616D Childrens Cough (SCRX) 2 oz. bottle For temporary relief of cough symptoms: dry or hoarse cough, hacking, barking, tickling or spasmodic cough, croupy cough and throat irritation, and excess mucus. 357955014522 091015B 120616B Children’s Ear Formula (SCRX) 2 oz. bottle For temporary relief of symptoms: clogged sensation, noises in ear, accumulation of ear wax. 357955075721 032316B Children’s Fever Reliever (SCRX) 2 oz. bottle For fast relief of fever, sweats, chills, shakes, aches, vomiting, rheumatic pains, muscular soreness, nausea, faintness, lethargy, fears, irritability, and oversensitivity. 357955015925 082516A 102015F Children’s Growth

& Development (SCRX) 2 oz. bottle To maximize children' s growth potential and enhance development. Stimulates the body's ability to digest‚ absorb and use food for maximum growth and development 357955014225 020917A 062716E Colic Relief (SCRX) 2 oz. bottle For temporary relief of: abdominal discomfort, pressure, and distention, spitting up, gas and bloating, cramping, pain, irritability, desire to be held constantly, weak digestion, restless sleep. 357955015826 111717E Newborn Tonic (SCRX) 2 oz. bottle For temporary relief of symptoms: skin rashes, discoloration, minor skin problems, pimples, restlessness. If symptoms persist for more than 7 days, consult your physician. 357955011422 110915H Teething (SCRX) 2 oz. bottle For temporary relief of symptoms: teething pain, irritated gums, delayed teething, fever- like disturbances, restlessness, heavy salivation and drooling, irritability, desire to be held constantly. 357955501824 032216C Tummy Aches (SCRX) 2 oz. bottle For temporary relief of symptoms: upset stomach, nausea, vomiting, aversion to food, stomach cramps, hollow, empty, or sinking feeling, pale or flushed skin, headaches. 357955014621 022316F Children’s Appetite

& Weight (SCRX) 2 oz. bottle temporarily brings relief to symptoms of contributing to:

excessive appetite; constitutional tendency to gain fat; cravings for sweats and starches; water retention; overeating; ravenous hunger; excess weight; abdominal fat. 357955251729 102016J Children’s Appetite Enhancer (SCRX) 2 oz. bottle For natural relief of loss of appetite, no desire to eat, aversion to food, and inability to bear the sight or smell of food. Helps to naturally revitalize after gradual loss of weight from impaired nutrition. 357955031826 022316G

SafeCare Rx For Professional Use Only

King Bio is notifying its distributors and customers by letter and is arranging for return and/or replacement of all recalled products. Consumers/distributors/retailers that have product which is being recalled should discontinue use/distribution and contact King Bio at recall@kingbio.com to make arrangements to return product. These products were distributed Nationwide to distributors and retail stores August 2017 – July 2018.

Consumers with questions regarding this recall can contact King Bio by 866-298-2740 or e-mail recall@kingbio.com, Monday – Thursday 830am – 330pm, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online: www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Company Contact Information Consumers: King Bio 866-298-2740 recall@kingbio.com