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February 8, 2000

Great Southern Laboratories Recalls Cyndal HD Cough Syrup

Houston, TX (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Great Southern Laboratories (GSL) is recalling Cyndal HD Cough Syrup because of subpotency of the phenylephrine (50%) due to incorrect weight addition in batch production.

The recalled Cyndal HD Cough Syrup (Hydrocodone Bitartrate 1.57mg/ Phenylephrine Hydrochloride 5mg/Chlorpheniramine Maleate 2mg), was sold in 16 fluid ounce (NDC 60258-703-16) and 1 gallon (NDC 60258-703-28) containers.

According to FDA, 118 gallon bottles and 7,032 pint bottles were distributed in the Southeastern United States.

The recalled vials can be identified by the Lot Number 91949.

This ongoing Class III recall was initiated by GSL by verbal communication on December 15, 1999, followed by letters dated December 21 and 30, 1999.  This is the first public notice issued by the FDA.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #D-209-0

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Health Professional:

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During 2000 there were over
1050 products recalled in the United
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