FDA-Drug2012-10-24Class III
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
Sandoz Incorporated
Hazard
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Sold states
Nationwide
Affected count
67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons
Manufactured in
2555 W Midway Blvd, N/A, Broomfield, CO, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-008-2013Don't want to check this manually?
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