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FOOD AND DRUG ADMINISTRATION
FOR IMMEDIATE RELEASE

Consumer Media: 888-Info-FDA
December 9, 1998

PRODUCT
Phenylpropanolamine Hydrochloride 75 mg/Chlorpheniramine Maleate 8 mg. extended release capsules packaged in bottles of 10, 20, and 30 count capsules, OTC under the following brand names:
a) AMERICAN FARE brand Cold Capsules Made for Kmart Corporation, Troy, Michigan 48084.  NDC 0113-0482-52;
b) AMERICAN FARE brand 12 Hour Cold Capsules Made for Kmart Corporation, Troy, Michigan 48084.  NDC 49738-482-60;
c) ARBOR brand Cold Caps Distributed by Arbor Drugs, Inc., Troy, Michigan 48084.  NDC 50165-482-60;
d) CVS cold capsules Distributed by CVS, Woonsocket, RI 02895. [Label bears no NDC#];
e)   equate brand cold capsules Distributed by Perrigo Co.,
Allegan, MI 49010  [Label bears no NDC#];
f) FOOD LION brand Cold Capsules Distributed by Food Lion Stores, Inc., Salisbury, NC 28144 NDC 55316-008-51;
g) health PRIDE brand Cold Capsules Distributed by Compass Foods, Montvale, NJ 07645.  [label bears no NDC#];
h) H-E-B PHARMACY brand Cold Caps Distributed by H-E-B, San Antonio, TX 78204;
i) Marquee brand Maximum Strength Severe Cold & Flu Cold Caps Distributed by Fleming Companies, Inc., Oklahoma City, OK 73216. NDC 11205-501-73;
j) The Medicine Shoppe brand Cold Capsules Distributed by Medicine Shoppe International, Inc., St. Louis, Missouri 63132. NDC 49614-482-52;
k) Meijer brand Cold Caps Dist. by Meijer, Inc., Grand Rapids, MI 49544.  NDC 41250-482-52;
l) RITE AID brand Cold Caps Distributed by Rite Aid Corporation, Harrisburg, PA 17105.  [label bears no NDC#];
m) SAFEWAY brand Cold Capsules Distributed by Safeway, Inc., P.O. Box 99, Pleasanton, CA 94566-0009.  NDC #21130-482-52;
n) Shurfine brand Cold Caps Distributed by Shurfine
International, Inc., Northlake, IL 60164-1889.  [label bears no NDC#];
o) ValueRite brand Cold Caps Distributed by McKesson Corp., One Pst Street, San Francisco, CA 94104.  NDC #49348-027-47;
p) VONS brand Cold Capsules Distributed by Vons, P.O. Box 99, Pleasanton, CA 94566-0009.  NDC # 58828-482-52;
q) Walgreens brand Cold Capsules Distributed by Walgreen Co., Deerfield, IL 60015-4681.  NDC # 0363-0482-65;
r) Wegmans brand Cold Capsules Distributed by Wegmans Food Markets, Inc., Rochester, NY 14692.  [label bears no NDC#];
s) Woolworth brand Cold Capsules Marketed by Woolworth Co., New York, NY 10279.  NDC # 12443-482-52.  Recall #D-034-9.

CODE
Schwarz Lot 1460012. Finished product lots 7HA113, 7HA133, 7HA134, 7HA165 AND 7HA270. Expiration date of all lots is 10/98. Lot 7HA113 was packaged in bottles of 10's. Lots 7HA133, 7HA165 and 7HA270 were packaged in bottles of 20's. Lot 7HA134 was packaged in bottles of 30's.

MANUACTURER: Schwarz Pharma Manufacturing, Inc., Seymour, Indiana.

RECALLED BY: Manufacturer, by telephone on June 16, 1998, and by letter dated June 28, 1998. Firm-initiated recall ongoing.

DISTRIBUTION
Nationwide.

QUANTITY
approximately 117, 276 Bottles were distributed.

REASON
Uniformity of dosage failure Chlorpheniramine Maleate-Superpotent.

 

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.