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Recall Observatory FDA recall evidence

Food 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.

F-1105-2014

November 07, 2013

Class II

Product summary

Firm
Global Health Laboratories, LLC
Event
Event 66765
Status
Terminated
Classification
Class II
Quantity
1495 bottles
Official record key
food-enforcement:F-1105-2014

Official wording

Reason: 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.

Code information: Lot Number 1256074

Distribution pattern: New York

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.