Class III
Terminated
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
- Company
- Sandoz Incorporated
- Recall Initiated
- September 20, 2012
- Posted
- October 24, 2012
- Recall Number
- D-008-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons
- Firm Location
- Broomfield, CO, United States
Reason for Recall
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Distribution
Nationwide
Lot / Code Info
NDC 0781-5283-64 lots: BT2862, BT7986, BT7994, BW0652, CC1961, and CA3437; NDC 0904-5878-33 lot BW0665.
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