Drug recall
Clorazepate Dipotassium Tablets, USP, 3.75 mg, a) 100 tablets per bottle, NDC 13107-282-01 b) 500 tablets per…
FDA recall event 94500 · Class II · Aurobindo Pharma USA Inc.
Key facts
| Event ID | 94500 |
|---|---|
| Recall numbers | D-0491-2024, D-0492-2024 |
| Recalling firm | Aurobindo Pharma USA Inc. |
| Product type | Drugs |
| Products | 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…, Clorazepate Dipotassium Tablets, USP, 7.5 mg, a) 100 tablets per bottle, NDC 13107-283-01, b) 500 tablets per bottle, NDC 13107-283-05, Rx Only, Distributed by Aurobindo Pharma USA, Inc., 279… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Discoloration: Dotted and yellow spots on tablets |
| Initiation date | Apr 24, 2024 |
| Report date | May 15, 2024 |
| City | East Windsor |
| State | NJ |
| Country | United States |
| FEI number | 3014213061 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: