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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
June 10, 1998

PRODUCT
Tincoben(R) Topical Protective Tincture (Benzoin, Aloe, Tolu Balsam and Storax), in 4 fluid ounce bottles, OTC, indicated for use as a topical protective. NDC #0496-0542-04.

Recall #D-168-6.

CODE
Lot #57-035 EXP 2/99.

MANUFACTURER
Ferndale Laboratories, Inc., Ferndale, Michigan.

RECALLED
BY Manufacturer, by letter on April 23, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
13,313 bottles were distributed.

REASON
Stability failure (below specification) for non-volatile residue.

 

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.