For the second time in 10 months, the FDA has issued an advisory to avoid liquid drug products made at Davie company PharmaTech after finding Burkholderia cepacia contamination in the products.
And three drug companies issued a sweeping all-lots, all-expiration-dates wholesale and retail recall of 22 over the counter liquid medications made by PharmaTech. This follows a recall of two Rugby Laboratories laxatives possibly contaminated with B. cepacia.
“Centers for Disease Control and Prevention laboratory testing of PharmaTech’s oral liquid docusate detected a strain of B. cepacia bacteria linked to recent patient infections,” the FDA wrote in its advisory. “Therefore, FDA recommends health care professionals and patients not use PharmaTech’s liquid drug products.”
Last October, the FDA found B. cepacia in the water system PharmaTech used to make the liquid drug products. Both the FDA and the CDC fingered PharmaTech as the root of the multistate B. cepacia outbreak.
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The CDC describes B. cepacia as an often-antibiotic resistant bacteria complex found in soil and water.
“B. cepacia poses little medical risk to healthy people,” the CDC writes. “However, people who have certain health problems like weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with B. cepacia. B. cepacia is a known cause of infections in hospitalized patients.”
Which brings us back to the 22 recalled medications, commonly used in hospitals and doctor’s offices, as well as homes.
Leader Brand recalled Liquid Multivitamin Supplement for Infants and Toddlers and Liquid Vitamin D Supplement for Breastfed Infants. Customers with questions can call 800-200-6313, hit option #1, Monday through Thursday, 8 a.m. to 7 p.m. Eastern time and Friday 8 a.m. to 5 p.m., Eastern time.
Major Pharmaceuticals recalled Certa Vite Liquid, Poly Vita Drops, Poly Vita Drops With Iron, Ferrous Drops Iron Supplement, D-Vita Drops, Tri-Vita Drops and Senna Syrup. Anyone with questions can call Rugby Laboratories/Major Pharmaceuticals Customer Support at 800-645-2158, Monday through Friday, 8 a.m. to 8 p.m., Eastern time.
Rugby Laboratories recalled C Liquid, Diocto Liquid, Ferrous Sulfate, Fer Iron Liquid, Diocto Syrup, Aller Chlor Syrup, Cerovite Liquid, D3 400iu Liquid, Poly-Vitamin Liquid, Tri-Vitamin Liquid and Poly Vitamin with Iron Liquid.
The FDA warns, “It might be difficult to determine the manufacturer because these liquid products are not labeled with a PharmaTech label. FDA advises health care facilities and pharmacies that think they might have liquid PharmaTech drug products, especially oral liquid docusate drug products, to check with their supplier to determine the identity of the manufacturer.”