Drug recall
Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S…
FDA recall event 77732 · Class II · Precision Dose Inc.
Key facts
| Event ID | 77732 |
|---|---|
| Recall numbers | D-1037-2017 |
| Recalling firm | Precision Dose Inc. |
| Product type | Drugs |
| Products | Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC. |
| Initiation date | Jul 5, 2017 |
| Report date | Aug 9, 2017 |
| Termination date | Mar 28, 2018 |
| City | South Beloit |
| State | IL |
| Country | United States |
| FEI number | 1419861 |
At a glance
- 1–9 Products in this recall
- 10–99 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: