Drug recall
ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL)…
FDA recall event 70168 · Class III · Qualitest Pharmaceuticals
Key facts
| Event ID | 70168 |
|---|---|
| Recall numbers | D-0331-2015 |
| Recalling firm | Qualitest Pharmaceuticals |
| Product type | Drugs |
| Products | ACETAMINOPHEN and CODEINE PHOSPHATE ORAL SOLUTION USP, 120 mg/12 mg per 5 mL, packaged in a) 4 oz. (120 mL) bottles, NDC 0603-9013-54, UPC 3 0603-9013-54 8 and b) ONE PINT (473 mL) bottles, NDC… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol. |
| Initiation date | Dec 22, 2014 |
| Report date | Jan 14, 2015 |
| Termination date | Feb 1, 2016 |
| City | Huntsville |
| State | AL |
| Country | United States |
| FEI number | 1000524784 |
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: