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October 1, 2003

Leiner Health Products Has Recalled Non-Aspirin Sinus Gelcaps

(SafetyAlerts) - The FDA has released the following information.

PRODUCT
Non-Aspirin Sinus Gelcaps, (Acetaminophen, 500mg and Pseudoehedrine HCl, 30mg), 24 Gelcaps blister packed cartons, Extra Strength, Pain Reliever/Nasal Decongestant, Pharmacist Formula is Marketed by: Leiner Health Products Carson, CA -----Also sold under other brand names as ----Pain Relief Sinus, Day Non-Drowsy, Extra Strength, Pain Reliever, Nasal Decongestant, 24 Gelcaps blister packed cartons, Longs brand, Distributed by Longs Drugs, Walnut Creek, CA----Non-Aspirin Sinus, Non-Drowsy, Extra Strength, 24 Gelatin Caplets blister packed cartons, American Fare brand, Made for Kmart Corporation, Troy, Michigan----Non-Drowsy Sinus, Non-Aspirin, Maximum Strength, Multi-Symptom Relief, Pain Reliever, Nasal Decongestant, 24 Gelatin Caplets blister packed cartons, Eckerd brand, Distributed by Eckerd Drug Company Clearwater, FL----Pain Reliever Sinus, Pain Reliever, Nasal Decongestant, Maximum Strength, 24 Gelatin Tablets blister packed cartons, ElectHealth brand, Distributed by: Shopko Stores, Inc. Green Bay, WI. Recall # D-327-3.

CODE
Lot Numbers 3EB1154 (Eckerd), 3EB1156 (American Fare), 3EB0999 (Longs), 3EB1155 (Longs), 3EB1157 (Pharmacist Formula) & 3EB1000 (ElectHealth).

RECALLING FIRM/MANUFACTURER
Leiner Health Products, Carlson, CA, by letters on August 5, 2003. Firm initiated recall is ongoing.

REASON
Mislabeling; Extended expiration date-product incorrectly bears expiry as 11/2005 rather than correct date of 12/2004.

VOLUME OF PRODUCT IN COMMERCE
864,000 pills.

DISTRIBUTION
Nationwide.

 
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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.