The U.S. Food and Drug Administration (FDA) is working to recall all products manufactured by PharmaTech LLC of Davie, Florida because several people developed infections with dangerous bacteria.
The main products that moms should watch out for is “Leader® Liquid Vitamin D Supplement for Breastfed Infants” and “Leader® Multivitamin Supplement for Infants and Toddlers.”
The bacteria Burkholderia cepacia (B. cepacia) was discovered in the water system at PharmaTech’s manufacturing facility, according to the FDA. Because the water was used to make all of PharmaTech’s liquid medications, all of those medications are now being recalled.
The recall involves a wide range of products that were sold under several brands, including “Leader,” “Major Pharmaceuticals,” and “Rugby Laboratories” — so if you have any of their various drops or supplements in your medicine cabinet, throw them out immediately.
PharmaTech has had ongoing problems with B. cepacia contamination. In August 2016, the FDA warned hospitals not to use “Rugby® Diocto Liquid Stool Softener” after an outbreak of B. cepacia caused 60 people to develop infections in 8 states.
After the outbreak, two unopened bottles of Diocto Liquid tested positive for B. cepacia. Further investigations determined that the water system at PharmaTech was contaminated with the bacteria.
Infections with B. cepacia are rare, but they have a 42% fatality-rate because the bacteria resists treatment with common antibiotics. It typically infects hospitalized patients with weak immune systems, but babies and toddlers are also vulnerable to infections.
The recalled products include:
|Liquid Multivitamin Supplement for Infants and Toddlers 50 mL,||UPC: 096295128611||ALL LOTS|
|Liquid Vitamin D Supplement for Breastfed Infants 400 IU 50 mL,||UPC: 096295128628||ALL LOTS|
|Certa-Vite Liquid||236ML||00904-5023-09||ALL LOTS|
|Poly-Vita Drops||50ML||00904-5099-50||ALL LOTS|
|Poly-Vita Drops W/Iron||50ML||00904-5100-50;||ALL LOTS|
|Ferrous Drops Iron Supp||50ML||00904-6060-50||ALL LOTS|
|D-Vita Drops||50ML||00904-6273-50||ALL LOTS|
|Tri-Vita Drops||50ML||00904-6274-50||ALL LOTS|
|Senna Syrup||237ML||00904-6289-09||ALL LOTS|
|C Liquid 500mg||118ML||00536-0160-97||ALL LOTS|
|Diocto Liquid 50mg/5ml||473ML||00536-0590-85||ALL LOTS|
|Ferrous Sulfate Elixir||473ML||00536-0650-85||ALL LOTS|
|Fer Iron Liquid 50ML||50ML||00536-0710-80||ALL LOTS|
|Senexon Liquid||237ML||00536-1000-59||ALL LOTS|
|Diocto Syrup 60MG/15ML||473ML||00536-1001-85||ALL LOTS|
|Aller Chlor Syrup||120ML||00536-1025-47||ALL LOTS|
|Calcionate Syrup||16OZ||00536-2770-85||ALL LOTS|
|Cerovite Liquid||236ML||00536-2790-59||ALL LOTS|
|D3 400iu Liquid||50ML||00536-8400-80||ALL LOTS|
|Poly-Vitamin Liquid||50ML||00536-8450-80||ALL LOTS|
|Tri-Vitamin Liquid||50ML||00536-8501-80||ALL LOTS|
|Poly-Vitamin W/Iron Liquid||50ML||00536-8530-80||ALL LOTS|