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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE
Consumer Media: 888-Info-FDA
June 9, 1999

Biocentrics Recalls Rejuvamin PM Capsules

Brentwood, TN (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Biocentrics is recalling Rejuvamin PM Capsules because the product is an unapproved new drug.

This is the first public notice issued by the FDA.

PRODUCT
Rejuvamin PM Capsules (Gammadeoxytetronic Acid), OTC in packets of 4 units.

CODE
All lot numbers

MANUFACTURER
Tishcon Corporation, Westbury, New York (contract Manufacturer).

RECALLED BY
Biocentrics, A Division of Unique Products Company, Brentwood, Tennessee, by letter dated April 20, 1999. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
Approximately 150 cases (each case containing 24 boxes with 30 packets inside the box) were manufactured. All of the product was distributed except 5 boxes (150 packets).

Recall #D-231-9.

 

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.