Recalls / Class II
Class IID-0197-2026
Product
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 07059. Vial NDC# 69097-708-31; Carton NDC 69097-708-96
- Brand name
- Phytonadione
- Generic name
- Phytonadione
- Active ingredient
- Phytonadione
- Route
- Intramuscular, Intravenous, Subcutaneous
- NDCs
- 69097-708, 69097-709
- FDA application
- ANDA214596
- Affected lot / code info
- Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025
Why it was recalled
Failed Stability Specifications: Observed OOS results: eg results for colour index
Recalling firm
- Firm
- Cipla Limited
- Manufacturer
- Cipla USA Inc.
- Type
- Voluntary: Firm initiated
- Address
- Plot No. 9 & 10, Pharma Zone Phase Ii, Section Iiii, Indore Special Economic Zone, Pithampur, District Dhar, N/A, India
Distribution
- Quantity
- 4,438 10x1mL cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2025-10-31
- FDA classified
- 2025-11-28
- Posted by FDA
- 2025-12-10
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0197-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.