February 8, 2000Great 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)
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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