The U.S. Meals and Drug Administration is advising customers and well being care professionals to not use any liquid drug or dietary complement merchandise manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby Laboratories, Main Prescription drugs and Chief Manufacturers, resulting from potential contamination with the micro organism Burkholderia cepacia (B. cepacia) and the danger for extreme affected person an infection.
The drug and dietary complement merchandise made by PharmaTech embrace liquid docusate sodium medicine (stool softeners), in addition to numerous dietary dietary supplements together with liquid vitamin D drops and liquid multivitamins marketed for infants and youngsters.
“B. cepacia poses a severe menace to weak sufferers, together with infants and younger kids who nonetheless have creating immune methods,” stated FDA Commissioner Scott Gottlieb, M.D. “These merchandise had been distributed nationwide to retailers, well being care services, pharmacies and bought on-line – making it essential that folks, sufferers and well being care suppliers be made conscious of the potential threat and instantly cease utilizing these merchandise.”
Based on the Facilities for Illness Management and Prevention (CDC), B. cepacia poses the best menace to hospitalized sufferers, critically ailing sufferers and other people with well being issues resembling weakened immune methods and power lung illnesses. The signs of B. cepacia infections differ extensively from none in any respect to severe respiratory infections. It might unfold from person-to-person by direct contact and is commonly proof against frequent antibiotics.
Customers, pharmacies and well being care services ought to instantly cease utilizing and dishing out all liquid drug and dietary complement merchandise manufactured by PharmaTech and labeled by Rugby Laboratories, Main Prescription drugs and Chief Manufacturers. These distributors voluntarily recalled the next merchandise:
- Liquid Multivitamin Complement for Infants and Toddlers 50 mL, UPC: 096295128611 ALL LOTS
- Liquid Vitamin D Complement 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 Complement 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
On Aug. eight, 2017, the FDA suggested well being care professionals and sufferers to not use any liquid drug merchandise manufactured by PharmaTech, following CDC’s laboratory testing of PharmaTech’s oral liquid docusate detected a pressure of B. cepacia linked to current affected person infections.
In 2016, the FDA suggested well being care professionals and sufferers to not use liquid docusate drug merchandise manufactured at PharmaTech’s Davie, Florida, facility after the merchandise had been implicated in CDC’s public well being investigation right into a multistate outbreak of B. cepacia infections.
The FDA encourages well being care professionals and customers to report antagonistic occasions or high quality issues skilled with using medicine and dietary dietary supplements merchandise to the FDA’s MedWatch Hostile Occasion Reporting program: