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SafetyAlerts
November 21, 2002

Great Southern Laboratories Has Recalled PRO-RED Syrup Antitussive, Nasal Decongestant, Antihistamine

(SafetyAlerts) - The Food and Drug Administration (FDA) has released the following information.

PRODUCT
PRO-RED Syrup Antitussive, Nasal Decongestant, Antihistamine, Alcohol Free, (Hydrocodone bitartrate 2mg, Phenylephrine hydrochloride 5mg, Pyrilamine maleate 8.33mg) 4 FL.OZ. (118 mL) and 16 FL.OZ. (473 mL) bottles, Rx Only. Recall # D-047-3.

CODE
Lot# 01092 Exp 06/2004.

RECALLING FIRM/MANUFACTURER
Great Southern Laboratories, Houston, TX, by meeting on September 10, 2002.
Firm initiated recall is ongoing.

REASON
Yeast contamination (saccromyces cervisiae) causing bottles to swell

VOLUME OF PRODUCT IN COMMERCE
3913 (16 oz bottles) and 315 (4 oz bottles).

DISTRIBUTION
MO, IA, and IL.

 

 
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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.