RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II ___________________________________

PRODUCT
Sertraline Hydrochloride Oral Concentrate, 20 mg/mL, 60 mL bottle, RX only, NDC 0054-0082-46, Recall # D-196-2008

CODE
Lots: 657694A, exp. Sep 08; 657695A, exp. Sep 08; 658085A exp. Jan 09 RECALLING FIRM/MANUFACTURER Boehringer Ingelheim Roxane Incorporated, Columbus, OH, by letters on March 5, 2008. Firm initiated recall is ongoing. 
REASON
Product does not meet degradation specifications over shelf life.
VOLUME OF PRODUCT IN COMMERCE
21,822 Units
DISTRIBUTION
Nationwide 

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III ___________________________________

PRODUCT
ACT Restoring Anticavity Fluoride Mouthwash (sodium fluoride 0.05%), Cool Splash Spearmint flavor, 18 fl oz. Recall # D-184-2008 CODE
Lot: RTP0078G, exp. 01/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Chattem Inc., Chattanooga, TN, by e-mail on March 17, 2008.
Manufacturer: Access Business Group Llc, Ada, MI. Firm initiated recall is ongoing. 
REASON
Some bottles are mislabeled as mint flavor instead of spearmint flavor and do not declare the presence of color ingredients green 3 and yellow 10.
VOLUME OF PRODUCT IN COMMERCE
26,976 units
DISTRIBUTION
Nationwide