King Bio Recalls Due To Potential Microbial Contamination Approach 500
Executive Summary
FDA deemed 469 homeopathic remedies manufactured by King Bio – marketed as Dr. King’s: Natural Medicine, Aquaflora, SafeCareRx and Safecare bands – and recalled since July as class I, indicating the agency considers that a violative product poses reasonable probability of serious adverse health consequences or death. Kingston Pharma recalls one lot of DG/health Naturals baby Cough Syrup + Mucus potentially contaminated and Ata Int.'s BlueFusion product marketed as a dietary supplement contains ED ingredients and other drugs.
The number of products that homeopathic drug manufacturer King Bio Inc. has recalled since July 2018 due to potential microbial contamination is approaching 500, according to the latest update to FDA's recalls database.
In other consumer health product recalls, on March 20 Kingston Pharma LLC announced that one lot of DG/health Naturals baby Cough Syrup + Mucus dietary supplement potentially is contaminated with Bacillus cereus or Bacillus circulans and on March FDA said 21 Ata Int. Inc.'s Blue Fusion product marketed as a supplement was found to contain erectile dysfunction ingredients and other drugs.
FDA's same-day update to its recalls database showed that 469 homeopathic remedies manufactured by King Bio – marketed as Dr. King’s: Natural Medicine, Aquaflora, SafeCareRx and Safecare bands – and recalled since July were deemed on March 8 as class I, indicating the agency considers that a violative product poses reasonable probability of serious adverse health consequences or death.
In addition to its aqueous-based liquids, oral sprays, nasal gels, creams, and lotions King Bio markets under its brands, 12 other products it provided as a contract manufacturer to Grand Rapids, Mich., firms BioLyte Laboratories LLC and HelloLife Inc., and to Beaumont Bio Med Inc. of Waukon, Iowa, are on recall due to potential .
Asheville N.C.-based King Bio's first recall announcement stated that the potential was from Pseudomonas Brenneri, Pseudomonas Fluroescens and Burkholderia Multivorans. (Also see "Dr. King's Homeopathics Recalled; MyNicNaxs Starts Recall 3 Months After FDA Shutdown" - HBW Insight, 23 Jul, 2018.)
Its own list of its recalls, which also includes animal care homeopathic products it makes and markets under the Natural Pet Pharmaceuticals and Natural Veterinary brands, includes 1,303 stock-keeping units with separate listings for different package sizes of the same products. FDA's list includes multiple package sizes under single product names.
A statement on the firm's website attributed to founder and President Frank King says the voluntary recall was "due to possible water-purity issues" and was done "out of an abundance of caution" because no reports of illness or injury due to any of its products had been reported before the first recall.
Following King Bio's announcement of its own product recalls, HelloLife within a month and Beaumont Bio and BioLyte Labs in September recalled their homeopathic products provided by King Bio. (Also see "Health, Beauty And Wellness Regulatory News: Warnings, Alerts, Recalls" - HBW Insight, 19 Sep, 2018.)
DG/health, Blue Fusion Recalls
Kingston Pharma is recalling one lot of its 2-fluid ounce (59 mL) of DG/health Naturals baby Cough Syrup + Mucus, labeled as containing English ivy leaf extract and organic agave syrup, distributed nationwide in Dollar General retail stores. Production has been suspended while FDA and the firm investigate to the source of the problem.
The potential for contamination was noted after audit testing; one in 10 showed low levels of Bacillus cereus and two in 10 showed low levels of Bacillus circulans. The firm said no illnesses have been reported in connection with the potential contamination.
Alt Int becomes the latest company that FDA has identified as marketing products labeled as supplements but spiked with drug ingredients. But unlike most other adulterated supplements marketed for male sexual enhancement, Ata Int.'s Blue Fusion capsules contained pharmaceuticals other than ingredients approved by FDA for use in Rx drugs indicated for ED.
In addition to ED drugs sildenafil and tadalafil, the products linked to Ata Int. contained desmethyl carbodenafil and dithiodesmethyl carbodenafil,, which are analogs of PDE-5 inhibitors and likely have the same pharmacological activity as PDE-5 inhibitors and the same clinical risks. The undeclared active ingredients render the product an unapproved drug.
All lots of Blue Fusion, sold in 1-count blister packs and also containing scutellarin and daidzein botanical ingredients, distributed in the US between January 2015 and March 2019 to retail stores and sold online are on recall.
FDA did not provide information on the location of Ata Int.