Safety

Announcement

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

A small percentage of our products produced between 08/01/2017 and 04/2018 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.

DescriptionPackagingIntended useUDF_UPCLOTLOTLOTLOTLOT
DK Attention
& Learning Enh.
2 oz. bottleA natural aid for: slow or difficult comprehension, overexcitement, writing wrong words or syllables, oversensitivity, forgetfulness, lack of assertiveness, shyness, apprehension.357955501527050216G070816C092617F
Chicken Pox Symptom Relief2 oz. bottleFor 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.357955602521021216K062716D
Children’s Appetite & Weight2 oz. bottleFor 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.357955551720080916M091316D050516E072516E
Children’s Appetite Enhance2 oz. bottlea natural aid for: loss of appetite, no desire to eat, aversion to food, and inability to bear the sight or smell of food.357955531821020117F060216E080916B092415F
Children’s Cough Relief2 oz. bottleFor temporary relief of cough symptoms: dry or hoarse cough, hacking, barking, tickling or spasmodic cough, croupy cough and throat irritation, and excess mucus.357955514527021216J030916T092815E
Children’s Fever Reliever2 oz. bottleFor symptomatic relief of: fever, sweats, chills, aches.357955515920021216H052616H102815C120816A
Children’s Growth & Development2 oz. bottleA natural aid for: impaired growth, weak muscular growth, loss of appetite, poor mineral absorption, nervousness, lack of focus, mental weakness, loss of confidence.357955514220050516E072516E
DK Newborn Tonic2 oz. bottleFor temporary relief of symptoms: skin rashes, discoloration, minor skin problems, pimples, restlessness. If symptoms persist for more than 7 days, consult your physician.357955511427063016K112315F
DK Nosebleed Relief2 oz. bottleFor temporary relief of: nosebleeds commonly associated with irritations or strains, colds, coughing, sneezing or menses. Also for nighttime nosebleeds.357955514022050516H080916J
TonsilPlex2 oz. bottleFor 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.357955501725041416K061616D
Children’s Ear Relief Formula2 oz. bottleFor temporary relief of symptoms: clogged sensation, noises in ear, accumulation of ear wax.357955531524072516G112315B050216P
DK Teething2 oz. bottleFor temporary relief of symptoms: teething pain, irritated gums, delayed teething, fever-like disturbances, restlessness, heavy salivation and drooling, irritability, desire to be held constantly.357955501824020717B110716C080317D111617E020118F
DK Colic Relief2 oz. bottleFor 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.357955515821092017A020118H
Tummy Aches2 oz. bottleFor temporary relief of symptoms: upset stomach, nausea, vomiting, aversion to food, stomach cramps, hollow, empty, or sinking feeling, pale or flushed skin, headaches.357955514626050516D072216Q021918B
Kids Multi- Strain Flu Relief2 oz. bottleTemporarily 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.357955042228071316A071316A111015B112015A
Kids Stress & Anxiety2 oz. bottleFor temporary relief of symptoms: minor anxiety, fear, irritability, nervousness, minor mood swings, restlessness, stage fright, nervous stomach, oversensitivity.357955042327070516E081016G
Kids Sleep Aid2 oz. bottleFor temporary relief of symptoms due to occasional sleeplessness: restlessness, nervousness, exhaustion, excitability, inability to fall or stay asleep, worry.357955042426063016D081016F
Kids Bed Wetting (NP)2 oz. bottleFor relief of involuntary urination during sleep, urinary disturbances, and restless sleep.357955501220111717C101615B
Kids Candida 4 oz4 oz. bottleFor 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.357955332244011416G011917R081016E092815AA041518H
Kids Attention & Learning (SCRX)2 oz. bottleA natural aid for: slow or difficult comprehension, overexcitement, writing wrong words or syllables, oversensitivity, forgetfulness, lack of assertiveness, shyness, apprehension.357955001522121617A032316C091216A
Bed Wetting Prevention (SCRX)2 oz. bottleFor relief of involuntary urination during sleep, urinary disturbances, and restless sleep.357955001225102216B
Chicken Pox Symptom Relief (SCRX)2 oz. bottleFor 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.
357955782520042616D
Childrens Cough (SCRX)2 oz. bottleFor temporary relief of cough symptoms: dry or hoarse cough, hacking, barking, tickling or spasmodic cough, croupy cough and throat irritation, and excess mucus.357955014522091015B120616B
Children’s Ear Formula (SCRX)2 oz. bottleFor temporary relief of symptoms: clogged sensation, noises in ear, accumulation of ear wax.357955075721032316B
Children’s Fever Reliever (SCRX)2 oz. bottleFor fast relief of fever, sweats, chills, shakes, aches, vomiting, rheumatic pains, muscular soreness, nausea, faintness, lethargy, fears, irritability, and oversensitivity.357955015925082516A102015F
Children’s Growth
& Development (SCRX)
2 oz. bottleTo maximize children’ s growth potential and enhance development. Stimulates the body’s ability to digest‚ absorb and use food for maximum growth and development357955014225020917A062716E
Colic Relief (SCRX)2 oz. bottleFor 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.357955015826111717E
Newborn Tonic (SCRX)2 oz. bottleFor temporary relief of symptoms: skin rashes, discoloration, minor skin problems, pimples, restlessness. If symptoms persist for more than 7 days, consult your physician.357955011422110915H
Teething (SCRX)2 oz. bottleFor temporary relief of symptoms: teething pain, irritated gums, delayed teething, fever- like disturbances, restlessness, heavy salivation and drooling, irritability, desire to be held constantly.357955501824032216C
Tummy Aches (SCRX)2 oz. bottleFor temporary relief of symptoms: upset stomach, nausea, vomiting, aversion to food, stomach cramps, hollow, empty, or sinking feeling, pale or flushed skin, headaches.357955014621022316F
Children’s Appetite
& Weight (SCRX)
2 oz. bottletemporarily 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.
357955251729102016J
Children’s Appetite Enhancer (SCRX)2 oz. bottleFor 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.357955031826022316G

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.

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

###



Source link