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SafetyAlerts
November 27, 2002

Kiel Laboratories Has Recalled R-Tanna S Pediatric Suspension and CP-Tannic Suspension

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

PRODUCT
a) R-Tanna S Pediatric Suspension (Chlorpheniramine
Tannate 4.5mg and Phenylephrine tannate 5 mg) 4 fl oz (118mL) bottles, Rx only. Recall # D-055-3;
b) CP-Tannic Suspension (Chlorpheniramine tannate 4.5mg
and Phenylephrine tannate 75mg) 4fl oz (118mL) and 16fl oz (473mL) bottles, Rx only. Recall # D-056-3.

CODE
a) Lot# GB024;
b) Lot# GA984, GA986, GB005, GB033 and GB036.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Kiel Laboratories, Inc., Gainesville, GA, by fax on/about September 12, 2002. Firm initiated recall is ongoing.

REASON
SUBPOTENT; R-Tanna S Pediatric Suspension for phenylephrine tannate (3 month stability); CP-Tannic Suspension for chlorpheniramine tannate ( 1 month stability).

VOLUME OF PRODUCT IN COMMERCE
a) 5463 bottles;
b) 12817 bottles.

DISTRIBUTION
OH and MS.

 
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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.