Sandoz Incorporated recalls Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., fo
Recalled October 24, 2012 · FDA recall D-008-2013 · Sandoz Incorporated
Hazard
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2) · FDA Class III
Units
67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons
Sold at
Nationwide
Description
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Product
Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ NDC 0781-5283-64 --- ALSO sold under Major brand All Day Allergy Children's Cetirizine HCl 5 mg, 5 count blister pack, Major Pharmaceuticals, Livonia, MI NDC 0904-5878-33
Manufacturer(s)
Sandoz Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →