Why it was recalled
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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot Number 1256074
Where it was sold
New York
What to do if you have this product
- Compare the brand, size, and lot/UPC codes on your package with the codes above.
- If it matches, don't eat it. Return it to the store for a refund or throw it away.
- Wash surfaces and containers that touched the product.
- If you feel sick after eating it, contact your doctor. In an emergency call 911.
Recall details
- Recall number
- F-1105-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 7, 2013
- FDA report date
- Dec 25, 2013
- Quantity
- 1495 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Global Health Laboratories, LLC
Original FDA data
Every field from FDA enforcement report F-1105-2014, exactly as published.
Show all FDA fields
- City
- Amityville
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 66765
- Address
- 9500 New Horizons Blvd
- Code information
- Lot Number 1256074
- Postal code
- 11701-1155
- Report date
- Dec 25, 2013
- Product type
- Food
- Recall number
- F-1105-2014
- Classification
- Class II
- Recalling firm
- Global Health Laboratories, LLC
- Product quantity
- 1495 bottles
- Termination date
- Mar 8, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- New York
- Recall initiation date
- Nov 7, 2013
- Initial firm notification
- Letter
- Center classification date
- Dec 18, 2013