|FOOD AND DRUG
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
April 28, 1999Nutritional Concepts Inc. Recalls Firewater Brand Liquid
Firewater brand Liquid, (2 (3H) Furanone di-hydro),
OTC in 2 and 16 fluid ounce bottles, reportedly intended to be used as a sleep aid. Recall
All lot numbers.
Phillips Pharmatech Labs, Inc., Largo, Florida (contract manufacturer).
Nutritional Concepts Inc., Davie, Florida, by letter on February 6, 1999. Firm-initiated
recall ongoing. See also FDA talk paper T99-5 dated January 21, 1999.
California, Florida, Nevada, New Jersey, New Mexico, Texas, Washington state.
4,499 16-ounce bottles and 945 2-ounce bottles were distributed.
Product is an unapproved new drug