Washington D.C. — 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.
| 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 [email protected] 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 [email protected], 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: fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form fda.gov/MedWatch/getforms.htmor 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.
