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 b

FDA recall notice · announced October 24, 2012 · Sandoz

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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)

Notes

Distribution: Nationwide
Lot/code information: NDC 0781-5283-64 lots: BT2862, BT7986, BT7994, BW0652, CC1961, and CA3437; NDC 0904-5878-33 lot BW0665.
Quantity: 67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons
Status: Terminated
Products in this recall event:
- 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 Al (D-008-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.