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SafetyAlerts
December 5, 2001

Leiner Health Recalls 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 is an OTC product containing 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 is an OTC product containing Diphenhydramine Hydrochloride 25 mg and Pseudoephedrine Hydrochloride 60 mg., Capsule-Shaped tablets, Recall #D-040-2.

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

RECALLING FIRM/MANUFACTURER

Recalling Firm:
Leiner Health Products, Inc. Carson, CA.

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
.

 
Selected Recent Recalls


Health Professional:

Did you know?
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.