All liquid products manufactured by PharmaTech have been recalled due to the risk of Burkholderia cepacia contamination. The US Food and Drug Administration (FDA) announced the voluntary recall of liquids distributed by Leader Brand, Major Pharmaceuticals and Rugby Laboratories, including various drugs and dietary supplements intended for use in infants and children.
Following reports of adverse events of B. cepacia infection in patients, the three distribution firms announced a recall of all lots of liquid products within expiry. The recalled products, manufactured at PharmaTech's FDA registered facility in Davie, Florida, were distributed nationwide to both wholesale and retail facilities, including pharmacies and hospitals. The firms notified distributors and customers by letter and arranged a full recall of all affected products. Pharmacies, hospitals, healthcare facilities, and consumers have been advised to stop using and dispensing the medication immediately.
B. cepacia poses a particular threat to patients in hospital, those who are critically ill, and people with health problems such as a weak immune system or chronic lung disease, according to the Centers for Disease Control and Prevention (CDC). Symptoms of infection are varied, ranging from no symptoms at all to serious respiratory infections. The infection can be spread between people by direct contact and it is often resistant to common antibiotics.
FDA commissioner Scott Gottlieb, MD, highlighted the danger posed by the potentially contaminated medicines and supplements, stating: "These products were distributed nationwide to retailers, health care facilities, pharmacies and sold online - making it important that parents, patients and health care providers be made aware of the potential risk and immediately stop using these products."
What to do if you have recalled medication?
Stop using any medication affected by the recall. If in doubt, consult a physician or a pharmacist for more information.
Consumers with questions about the recall were advised to call Rugby Laboratories/Major Pharmaceuticals Customer Support line at 1-800-645-2158. Lines are open between Monday and Friday 08:00-20:00 EST.
Alternatively, call Leader Customer Support at 1-800-200-6313, option #1 Monday to Thursday 08:00-19:00 and Friday 08:00-17:00 EST.
Any problems with the product or adverse reactions can be reported to the FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm, using a form downloaded at www.fda.gov/MedWatch/getforms.htm, or with a form requested by calling 1-800-332-1088.
The full list of recalled products released by the FDA included Diocto Syrup and Diocto Liquid (docusate sodium solutions). All lots of each product listed below were recalled.
LEADER BRAND
Liquid Multivitamin Supplement for Infants and Toddlers 50 ml, UPC: 096295128611
Liquid Vitamin D Supplement for Breastfed Infants 400 IU 50 ml, UPC: 096295128628
MAJOR PHARMACEUTICALS
Certa-Vite Liquid 236ml 00904-5023-09
Poly-Vita Drops 50ml 00904-5099-50
Poly-Vita Drops W/Iron 50ml 00904-5100-50;
Ferrous Drops Iron Supp 50ml 00904-6060-50
D-Vita Drops 50ml 00904-6273-50
Tri-Vita Drops 50ml 00904-6274-50
Senna Syrup 237ml 00904-6289-09
RUGBY LABORATORIES
C Liquid 500mg 118ml 00536-0160-97
Diocto Liquid 50mg/5ml 473ml 00536-0590-85
Ferrous Sulfate Elixir 473ml 00536-0650-85
Fer Iron Liquid 50ml 50ml 00536-0710-80
Senexon Liquid 237ml 00536-1000-59
Diocto Syrup 60mg/15ml 473ml 00536-1001-85
Aller Chlor Syrup 120ml 00536-1025-47
Calcionate Syrup 16oz 00536-2770-85
Cerovite Liquid 236ml 00536-2790-59
D3 400iu Liquid 50ml 00536-8400-80
Poly-Vitamin Liquid 50ml 00536-8450-80
Tri-Vitamin Liquid 50ml 00536-8501-80
Poly-Vitamin W/Iron Liquid 50ml 00536-8530-80
