Earlier this month, the U.S. Food and Drug Administration advised the public of a joint voluntary recall issued by three distribution firms: Leader Brand, Major Pharmaceuticals, and Rugby Laboratories. This recall involves liquid drug and dietary supplement products manufactured by PharmaTech LLC at its FDA registered facility in Davie, Florida. This is a voluntary recall of all affected lots, within their expiration dates, due to possible product contamination with the bacteria Burkholderia cepacia (B. cepacia) and the risk for severe patient infection. Although this particular bacterium often poses little medical risk to otherwise healthy individuals, White Oak Pediatrics would like to bring this recall to the attention of our patients, as many of the products affected, including liquid vitamin D, are for use with infants and children.
Drug and Dietary Supplements Affected
The products affected by this nationwide recall by PharmaTech LLC include vitamin D supplements and other liquids intended for use with small children. Within the Leader Brand, these include: 50ML bottles of Liquid Multivitamin Supplement for Infants and Toddlers, and 50ML bottles of Liquid Vitamin D Supplement for Breastfed Infants.
Within the Major Pharmaceuticals brand, this recall includes: 236ML bottles of Certa-Vite Liquid, 50ML bottles of Poly-Vita Drops, 50ML bottles of Poly-Vita Drops with Iron, 50ML bottles of Ferrous Drops Iron Supplement, 50 ML bottles of D-Vita Drops, 50ML bottles of Tri-Vita Drops, and 237ML bottles of Senna Syrup.
Finally, within the Rugby Laboratories brand, this recall includes: 118ML bottles of C Liquid, 473ML bottles of Diocto Liquid, 473ML bottles of Ferrous Sulfate Elixir, 50ML bottles of Fer Iron Liquid, 237ML bottles of Senexon Liquid, 473ML bottles of Diocto Syrup, 120ML bottles of Aller Chlor Syrup, 16OZ bottles of Calcionate Syrup, 236ML bottles of Cerovite Liquid, 50ML bottles of D3 Liquid, 50ML bottles of Poly-Vitamin Liquid, 50ML bottles of Tri-Vitamin Liquid, and 50ML bottles of Poly-Vitamin with Iron Liquid.
Vitamin D Drops and Liquid Multivitamins
As a parent of a small child, please ensure that you check your medicine cabinet for all of the above affected lots. If you are in possession of any liquid drug products manufactured by PharmaTech, please stop using them immediately.
If you or your child have been affected by any liquid drug and dietary supplement products manufactured by PharmaTech LLC, please inform the U.S. Food and Drug Administration as soon as possible, by filling out a MedWatch Online Voluntary Reporting Form. Once completed, you are able to submit the form online to the FDA, or you can submit it via fax at 1-800-FDA-0178.
If you have any questions or would like to schedule an appointment for your child to see a doctor, do not hesitate to contact White Oak Pediatrics. Our knowledgeable team of doctors will be able to put your mind at ease, ensuring that your child remains strong and healthy for years to come.