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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
April 28, 1999

Nutritional Concepts Inc. Recalls Firewater Brand Liquid Sleep Aid

PRODUCT
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 #D-195-9.

CODE
All lot numbers.

MANUFACTURER
Phillips Pharmatech Labs, Inc., Largo, Florida (contract manufacturer).

RECALLED BY
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.

DISTRIBUTION
California, Florida, Nevada, New Jersey, New Mexico, Texas, Washington state.

QUANTITY
4,499 16-ounce bottles and 945 2-ounce bottles were distributed.

REASON
Product is an unapproved new drug

 

The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.