miércoles, 10 de agosto de 2016

FDA MedWatch - Liquid Drug and Dietary Supplement Products by PharmaTech: Recall - Risk of Product Contamination

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Liquid Drug and Dietary Supplement Products by PharmaTech: Recall - Risk of Product Contamination

Including drug products:
Aller-chlor Antihistamine 
Diocto Syrup
Docusate Sodium
Ninjacof A
Senexion Liquid
Senna Syrup
Sennazon Syrup
Including dietary supplement products:
Calcionate Syrup
Cerovite Liquid
CertaVite with Antioxidants
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
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
Read the MedWatch safety alert, including a link to the press release, at:

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