FDA recall F-1105-2014

Product

UT-Fem¿ FOR WOMEN, urinary tract SOLUTION, Dietary Supplement, 42 Vegetable Capsules, Product No. 110403, UPC 7 98304 24865 4 -- Manufactured for: Global Quality Health Inc.

Reason for recall

The finished dietary supplement product was manufactured with ingredients subsequently found to be contaminated with chloramphenicol, an antibiotic, at levels above 0.3 ppb. The supplier, Specialty Enzymes & Biotechnologies, recalled the raw materials and notified the recipients. Subsequent private laboratory testing of the finished product revealed levels of chloramphenicol above 0.3 ppb.

Distribution

New York

Key facts

Status

Terminated

Initiation date

2013-11-07

Report date

2013-12-25

Termination date

2017-03-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Amityville, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1105-2014