Drug recall
Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd…
FDA recall event 97909 · Class II · Cipla Limited
Key facts
| Event ID | 97909 |
|---|---|
| Recall numbers | D-0197-2026 |
| Recalling firm | Cipla Limited |
| Product type | Drugs |
| Products | Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, Inc. Warren, NJ… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Failed Stability Specifications: Observed OOS results: eg results for colour index |
| Initiation date | Oct 31, 2025 |
| Report date | Dec 10, 2025 |
| City | Pithampur, District Dhar |
| Country | India |
| FEI number | 3008581988 |
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: