Home / Recalls / Sandoz Incorporated / D-008-2013

D-008-2013 Class III Terminated

Recalled by Sandoz Incorporated — Broomfield, CO

Recall Details

Product Type
Drugs
Report Date
October 24, 2012
Initiation Date
September 20, 2012
Termination Date
January 14, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons

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)

Distribution Pattern

Nationwide

Code Information

NDC 0781-5283-64 lots: BT2862, BT7986, BT7994, BW0652, CC1961, and CA3437; NDC 0904-5878-33 lot BW0665.

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