King Bio, which recalled 32 children’s medicines last week, made a sweeping expansion of that recall Monday to cover all aqueous-based products for children, adults, cats and dogs across its seven brands.
On its website, King Bio describes the problem as a “water-purity issue.” But in the company-written FDA-posted recall notice, King Bio says the problem is a “microbial contamination,” as it did in announcing last week’s children’s medicine’s recall.
Tuesday afternoon, the FDA provided more detail in a consumer alert.
“According to the company, several microbial contaminants were found in its products, including Burkholderia Multivorans, which is a strain of bacteria called Burkholderia cepecia complex (BCC) that can cause illness in people with compromised immune systems,” the alert said. “Additionally, evidence collected during the FDA’s inspection indicates recurring microbial contamination associated with the water system used to manufacture drug products.”
The FDA’s criticism of homeopathic products, which some consider a natural alternative to Big Pharma products, goes back a couple of years. No such products receive FDA approval before hitting the market.
“These unapproved drugs may cause significant and even irreparable harm if they are poorly manufactured, which can lead to contamination, or contain active ingredients that aren’t adequately tested or disclosed to patients, such as belladonna, which the agency has previously warned against,” the alert reads.
The brands affected are Dr. King’s: Natural Medicine, Aquaflora, Natural Pet Pharmaceuticals, SafeCareRx, Natural Veterinary, and Safecare. The products were distributed nationwide until Friday.
The lot numbers for each of the 32 brands of kids’ products are listed in this FDA recall notice from last week. The lot numbers for the over 100 brands of adult products and 20 kinds of over-the-counter pet products that include products for adult dust mite allergy and pet anxiety, are on the King Bio website.
For those who want to return recalled products for refund, email the company at firstname.lastname@example.org. Anyone with questions can email that address or call 866-298-2740, Monday through Thursday, 8:30 a.m. to 3:30 p.m., Eastern time.