Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by ...
FDA Recall #D-008-2013 — Class III — September 20, 2012
Product Description
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
Reason for Recall
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Recalling Firm
Sandoz Incorporated — Broomfield, CO
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons
Distribution
Nationwide
Code Information
NDC 0781-5283-64 lots: BT2862, BT7986, BT7994, BW0652, CC1961, and CA3437; NDC 0904-5878-33 lot BW0665.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated