FDA Drug recall D-0491-2024
Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx…
- FDA Drug
- Class II
- ongoing
- Published 2024-05-15
On 2024-05-15 the FDA classified a Class II recall of Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx… by Aurobindo Pharma Usa, citing discoloration: Dotted and yellow spots on tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0491-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-24 |
| Published | 2024-05-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Aurobindo Pharma Usa |
| Distribution | US |
Product
Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per bottle, NDC 13107-282-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.
Reason
Discoloration: Dotted and yellow spots on tablets
Identifiers
| ndc | 13107-282-01 |
|---|---|
| ndc | 13107-282-05 |
| ndc | 13107-283-01 |
| ndc | 13107-283-05 |
| ndc | 13107-284-01 |
| code_info | Lot #s: a) CZA124001B, CZA124002B, CZA124003B, Exp. 12/31/2025; b) CZA124001A, CZA124003A, Exp. 12/31/2025. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0491-2024%22
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