Including drug products:
Aller-chlor Antihistamine Diocto Syrup Docusate Sodium Ninjacof Ninjacof A Senexion Liquid Senna Syrup Sennazon Syrup Virtrate-2 Virtrate-K
Including dietary supplement products:
Calcionate Syrup Cerovite Liquid CertaVite with Antioxidants CytoDetox D3 Vitamin Liquid D-Vita Drops Fer-iron Liquid Ferrous Drops Ferrous Sulfate Liquid Liquid Vitamin C Pedia D-Vite Drops Pedia Poly-Vite Drops Pedia Tri-Vite Drops Poly-Vita Drops Poly-Vita Drops with Iron Polyvitamin liquid Polyvitamin liquid with Iron Renew HC Tri-Vita Drops Tri-Vitamin liquid
[Posted 08/09/2016]
AUDIENCE: Pediatrics, Pharmacy, Family Practice, Consumer
ISSUE: PharmaTech, LLC is voluntarily recalling all liquid products due to a potential risk of product contamination with Burkholderia cepacia. See the press release for a complete listing of affected products.
If a product contains B. cepacia, its use could result in infections in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis. Some of these infections may be serious or even life-threatening in the at risk patient population.
BACKGROUND: This recall affects all liquid products from October 20, 2015 through July 15, 2016.
RECOMMENDATION: PharmaTech, LLC is notifying its distributors and customers by recall letter and is arranging for return of all recalled products. Consumers, pharmacies, and healthcare facilities that have product which is being recalled should stop using and dispensing them immediately.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[08/08/2016 - Press Release - PharmaTech]
