After some of their medications tested positive for microbial contamination, King Bio issued a recall for nearly three dozen medications for infants and children, the U.S. Food and Drug Administration announced Wednesday.
The company said the recall was "out of an abundance of caution"
They said giving a child medication that has microbial contamination could make their infection worse or even cause life-threatening complications.
But the company said it has not yet received any reports of injury or illness from its medications.
Dr. Michael Hardin, a pediatrician at Family Medical Center in Orange Park, said the American Academy of Pediatrics in general says children should avoid over-the-counter medicationss when they can.
“They don’t advise using any over-the-counter cough or cold medications, especially children under 6 years of age,” Hardin said. “There are no directions on most over-the-counter products to know how to dose those, and they frequently cause more side effects than they help.”
The products affected by the King Bio recall are:
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
TonsilPlex
Children's Ear Relief Formula
DK Teething
DK Colic Relief
Tummy Aches
Kids Multi-Strain Flu Relief
Kids Stress & Anxiety
Kids Sleep Aid
Kids Bed Wetting (NP)
Kids Candida 4 oz
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)
Teething (SCRX)
Tummy Aches (SCRX)
Children’s Appetite & Weight (SCRX)
Children’s Appetite Enhancer (SCRX)
For the exact UPC and lot numbers affected, click here.
“Most of those teething relief medications have been taken off the market because they’re found to be ineffective or even dangerous,” Hardin said.
Hardin said pain relievers like Tylenol can be useful, but beyond that it’s helpful to avoid over-the-counter meds for children.
King Bio said consumers and distributors should immediately stop using and distributing the medications and can contact the company at recall@kingbio.com to make arrangements to return the product.
Consumers with questions regarding the recall can contact King Bio at 866-298-2740 or email recall@kingbio.com, Monday through Thursday 8:30 a.m.-3:30 p.m. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking or using this product, the company said.
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