FDA Drug recall D-1296-2014
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
- FDA Drug
- Class III
- terminated
- Published 2014-05-07
On 2014-05-07 the FDA classified a Class III recall of Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83 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-1296-2014 |
| 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
Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
Reason
Failed Impurities/Degradation Specifications: out of specification results for impurities/degradation testing for N-Oxide
Identifiers
| code_info | JKM2067A Exp. 07/14, JKM2068A Exp.10/14, JKM2069A Exp. 01/15, JKM6399A 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.
Other recalls by Caraco Pharmaceutical Laboratories
- Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only,…
FDA Drug · Class II · 2014-08-13 · Caraco Pharmaceutical Laboratories - Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only,…
FDA Drug · Class II · 2014-08-13 · Caraco Pharmaceutical Laboratories - Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles
FDA Drug · Class II · 2014-07-09 · Caraco Pharmaceutical Laboratories - Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmac…
FDA Drug · Class II · 2014-07-02 · Caraco Pharmaceutical Laboratories - Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5)
FDA Drug · Class II · 2014-05-07 · Caraco Pharmaceutical Laboratories
All Caraco Pharmaceutical Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1296-2014%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.