AUDIENCE: Consumer, Patient, Surgery
ISSUE: R-Kane Products, Inc, Pennsauken, NJ is recalling all outstanding supplies of its Z PRO HIGH PROTEIN SUPPLEMENT, because it contains soy and milk, allergens which are not declared on the labels of individual packets of the product. People who have an allergy or severe sensitivity to soy or milk run the risk of a serious or life-threatening allergic reaction if they consume these products.
BACKGROUND: Z PRO HIGH PROTEIN SUPPLEMENT was distributed nationwide between January 1, 2006 and January 24, 2013, to bariatric centers and bariatric physicians who dispense the product to patients who have undergone bariatric surgery. This recall was initiated after an FDA inspection noted that these allergens were not disclosed on the inner packets of the product. Product shipped after January 24, 2013 contains the allergen disclosure on both the outer box packaging and the individual inner packets of the product. No illnesses have been reported to date.
RECOMMENDATION: Additional information on what consumers should do with the product maybe be obtained by calling Robert Kaskey, 1-856-663-0644 (M–F 10 AM to 4:00 PM EST).
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.htm
- 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
[01/30/2013 - Press Release - R-Kane Products, Inc.]