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SafetyAlerts
January 17, 2002

Pharmacon Labs Has Recalled Poly-Tussin Syrup

Tampa, FL  (SafetyAlerts) - The Food and Drug Administration (FDA) said that Pharmacon Labs, Inc has recalled Poly-Tussin Syrup Sugar Free/Alcohol Free Sorbitol Free/Sodium Free 16 oz bottles, Rx Only Each 5 mL (one teaspoonful) for oral administration contains: Hydrocodone Bitartrate 5 mg, Phenylephrine Hydrochloride 5 mg, and Chlorpheniramine Maleate 2 mg.

PRODUCT
Poly-Tussin Syrup Sugar Free/Alcohol Free Sorbitol Free/Sodium Free 16 oz bottles, Rx Only Each 5 mL (one teaspoonful) for oral administration contains:
Hydrocodone Bitartrate 5 mg, Phenylephrine Hydrochloride 5 mg, and Chlorpheniramine Maleate 2 mg. Recall # D-079-2.

CODE
Lot # 1E04, exp 05/03

RECALLING FIRM/MANUFACTURER
Pharmacon Labs, Inc. Tampa, FL , by telephone and letters on 7/17/01. Firm initiated recall is ongoing.

REASON
Superpotentcy : Hydrocodone Bitartrate and Phenylephrine HCl.

VOLUME OF PRODUCT IN COMMERCE
1,313 16 oz bottles.

DISTRIBUTION
KY
.

 
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During 2000 there were over
1050 products recalled in the United
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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.