Drug recall
Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count…
FDA recall event 78359 · Class III · Precision Dose Inc.
Key facts
| Event ID | 78359 |
|---|---|
| Recall numbers | D-0057-2018 |
| Recalling firm | Precision Dose Inc. |
| Product type | Drugs |
| Products | Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Subpotent Drug: low out of specification results. |
| Initiation date | Sep 25, 2017 |
| Report date | Nov 8, 2017 |
| Termination date | Apr 23, 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: