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Poly-Vita Drops with Iron FDA Alerts

The FDA Alert(s) below may be specifically about Poly-Vita Drops with Iron or relate to a group or class of drugs which include Poly-Vita Drops with Iron (multivitamin with iron).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for multivitamin with iron

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

Aug 9, 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.

Drug products include:
Aller-chlor Antihistamine
Diocto Syrup
Docusate Sodium
Ninjacof
Ninjacof A
Senexion Liquid
Senna Syrup
Sennazon Syrup
Virtrate-2
Virtrate-K

Dietary supplement products include:
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  

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]
 

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