FDA Drug recall D-008-2013
Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Prin…
- FDA Drug
- Class III
- terminated
- Published 2012-10-24
On 2012-10-24 the FDA classified a Class III recall of Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Prin… by Sandoz, citing impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-008-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-09-20 |
| Published | 2012-10-24 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Sandoz |
| Distribution | US |
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
Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
Identifiers
| ndc | 0781-5283-06 |
|---|---|
| ndc | 0781-5283-64 |
| ndc | 0904-5878-33 |
| code_info | NDC 0781-5283-64 lots: BT2862, BT7986, BT7994, BW0652, CC1961, and CA3437; NDC 0904-5878-33 lot BW0665. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-008-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.