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SafetyAlerts
December 12, 2001

Leiner Health Products Has Recalled Equate Allergy Medication Decongestant Caplets

Carson, CA  (SafetyAlerts) - The Food and Drug Administration (FDA) said that Leiner Health Products, Inc. has recalled Equate Allergy Medication Decongestant Caplets in 24 caplet blister cartons. The product contains Diphenhydramine Hydrochloride 25 mg and Pseudoephedrine Hydrochloride 60 mg.

This is the first public notice of this Class lI recall issued by the FDA.

PRODUCT
Equate Allergy Medication Decongestant Caplets in 24 caplet blister cartons. The product contains Diphenhydramine Hydrochloride 25 mg and Pseudoephedrine Hydrochloride 60 mg., Recall D-040-2.

CODE
Lot No. 1GB0825, 1GB1041, 1GB1042.

RECALLING FIRM/MANUFACTURER
Recalling Firm:
Leiner Health Products, Inc., Carson, CA, by letter on 10/12/01.

Manufacturer:
Leiner Health Products, Inc., Fort Mill, SC. Firm initiated recall is ongoing.

REASON
Misbranding; directions for use may lead to a doubling of the dosage.

VOLUME OF PRODUCT IN COMMERCE
45,504/24 caplet cartons.

DISTRIBUTION
Nationwide
.

 
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Health Professional:

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During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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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.