Drug recall D-008-2013
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
Reason for recall
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Lots and codes
NDC 0781-5283-64 lots: BT2862, BT7986, BT7994, BW0652, CC1961, and CA3437; NDC 0904-5878-33 lot BW0665.
Recall details
- Recalling firm
- Sandoz Incorporated, Broomfield, CO
- Quantity
- 67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- September 20, 2012
- Terminated
- January 14, 2013
Related products
- Cetirizine hydrochloride – drug information
- NDC 0781-5283 Cetirizine Hydrochloride · Cetirizine Hydrochloride 5 mg/1 · Sandoz Inc