Drug 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
D-008-2013
Product summary
- Event
- Event 63224
- Status
- Terminated
- Classification
- Class III
- Quantity
- 67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons
- Official record key
drug-enforcement:D-008-2013
Official wording
Reason: Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Code information: NDC 0781-5283-64 lots: BT2862, BT7986, BT7994, BW0652, CC1961, and CA3437; NDC 0904-5878-33 lot BW0665.
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)