Drug recall
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only…
FDA recall event 87195 · Class III · Lupin Pharmaceuticals Inc.
Key facts
| Event ID | 87195 |
|---|---|
| Recall numbers | D-0247-2021 |
| Recalling firm | Lupin Pharmaceuticals Inc. |
| Product type | Drugs |
| Products | Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin… |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point. |
| Initiation date | Jan 21, 2021 |
| Report date | Feb 10, 2021 |
| Termination date | Dec 16, 2021 |
| City | Baltimore |
| State | MD |
| Country | United States |
| FEI number | 3004097115 |
At a glance
- 1–9 Products in this recall
- 1–9 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: