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10/5/03 at 2:09pm
Thread Starter 
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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