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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
March 4, 1998

PRODUCT
Prozac Pulvules (Fluoxetine Hydrochloride capsules),
10 mg, in units of 100 and 2000 count bottles, Rx indicated for the treatment of depression, obsessive-compulsive disorder and bulimia nervosa, under the Dista label.
NDC #0777-3104-02 BOTTLES OF 100
NDC 0777-3104-07 BOTTLES OF 2000.

Recall #D-082-8.

CODE

LOT NUMBER EXP. DATE PACKAGE
1AH81B JULY 1, 1999 100 CAPSULES
1AH82B JULY 1, 1999 100 "
1AH83M JULY 1, 1999 2000 "
1AG33M JULY 1, 1999 2000 "
1AG34M JULY 1, 1999 2000 "
1AG35M JULY 1, 1999 2000 ".

MANUFACTURER

Lilly Del Caribe, Inc., Carolina, Puerto Rico.
Shionogi Qualicaps, Whitsett, North Carolina
(capsule supplier).

RECALLED BY

Eli Lilly Company, Indianapolis, Indiana, by
letter and by fax on January 22, 1998.
Firm-initiated recall ongoing.

DISTRIBUTION

Nationwide.

QUANTITY

106,190 bottles were distributed.

REASON

Misbranded - Some capsules are incorrectly
imprinted as "20 mg units" and incorrectly item
coded for 20 mg capsules as "3105".

 

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.