SafetyAlerts
November 27, 2002
Kiel Laboratories Has Recalled R-Tanna S
Pediatric Suspension and CP-Tannic Suspension
(decongestant;
antihistamine)
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.
