Drug recall
Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in…
FDA recall event 64676 · Class II · Precision Dose Inc.
Key facts
| Event ID | 64676 |
|---|---|
| Recall numbers | D-250-2013 |
| Recalling firm | Precision Dose Inc. |
| Product type | Drugs |
| Products | Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 68094-650-59), packaged in 30-count cups per shipper case (NDC 68094-650-62), Pkg. By: Precision Dose, Inc., S. Beloit, IL… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product's name includes the word "Children's" which is misleading since the 650 mg dose of acetaminophen… |
| Initiation date | Mar 21, 2013 |
| Report date | Apr 24, 2013 |
| Termination date | May 7, 2015 |
| 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: