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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
August 26, 1998

PRODUCT
Casanthranol and Docusate Sodium Capsules, 30/100 mg, in 60 and100 capsule bottles, OTC laxative and stool softener, under theGood Neighbor Pharmacy and Brite-Life labels. Recall #D-224-8.

CODE
Good Neighbor 60s, NDC 24385-495-72,BBC # 792-242, Lots:F032 (exp. date 2/2000), F047 (2/2000), F055 (3/2000), F088(5/2000), F107 (4/2000), F138A (6/2000).Good Neighbor 100s, NDC 24385-495-78, BBC # 897-074, Lots: E288(12/1999), F088A (5/2000).Brite Life 60s, NDC 24385-495-72, BBC # 791-988, Lots: F032(2/2000), F047 (2/2000), F066 (3/2000), F107 (4/2000), F138 (6/2000).Brite Life 100s, NDC 24385-495-78, BBC # 897-363, Lots: E289(12/1999), F088A (5/2000).

MANUFACTURER
RP Scherer North America, St. Petersburg, Florida.

RECALLED BY
PL Developments, Inc., Farmingdale, New York, by telephone onJuly 22, 1998, followed by letter on July 29, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Michigan and California.

QUANTITY
50,277 bottles of all lots and sizes were distributed.

REASON
Immediate container label lacks directions for use/dosageinstructions.

 

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.