FDA Drug recall D-1297-2014
Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed…
- FDA Drug
- Class III
- terminated
- Published 2014-05-07
On 2014-05-07 the FDA classified a Class III recall of Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed… by Caraco Pharmaceutical Laboratories, citing failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1297-2014 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2014-04-09 |
| Published | 2014-05-07 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Caraco Pharmaceutical Laboratories |
| Distribution | US |
Product
Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83
Reason
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Identifiers
| code_info | JKM2070A Exp. 07/14, JKM2071A Exp.10/14, JKM2072A Exp. 01/15, JKM2072B Exp. 01/15, JKM6400A Exp. 04/15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1297-2014%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.