(FDA) - 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.
A full list of the recalled medicines and lot numbers are available on the FDA's website. The recall includes certain lots of 2-ounce bottles of the following products:
DK Attention & Learning Enh.
Chicken Pox Symptom Relief
Children's Appetite & Weight
Children's Appetite Enhance
Children's Cough Relief
Children's Fever Reliever
Children's Growth & Development
DK Newborn Tonic
DK Nosebleed Relief
Children's Ear Relief Formula
DK Colic Relief
Kids Multi- Strain Flu Relief
Kids Stress & Anxiety
Kids Sleep Aid
Kids Bed Wetting (NP)
Kids Candida 4 oz
The recall also includes certain lots of 2-ounce bottles of these medications, SafeCare Rx For Professional Use Only:
Kids Attention & Learning (SCRX)
Bed Wetting Prevention (SCRX)
Chicken Pox Symptom Relief (SCRX)
Children's Cough (SCRX)
Children's Ear Formula (SCRX)
Children's Fever Reliever (SCRX)
Children's Growth & Development (SCRX)
Colic Relief (SCRX)
Newborn Tonic (SCRX)
Tummy Aches (SCRX)
Children's Appetite & Weight (SCRX)
Children's Appetite Enhancer (SCRX)
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 firstname.lastname@example.org 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@example.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.
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