The FDA issued a notice regarding the recall of a wide variety of liquid drug and dietary supplement products by PharmaTech. This notice is particularly critical for people living with CF since the products are widely used by the CF community and the contamination involves Burkholderia cepacia.
Here is the text of the FDA press release:
Liquid Drug and Dietary Supplement Products by PharmaTech: Recall – Risk of Product Contamination
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