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
Reported: December 10, 2025 Initiated: October 31, 2025 #D-0197-2026
Product Description
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
Reason for Recall
Failed Stability Specifications: Observed OOS results: eg results for colour index
Details
- Recalling Firm
- Cipla Limited
- Units Affected
- 4,438 10x1mL cartons
- Distribution
- Nationwide in the USA
- Location
- Pithampur, District Dhar
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Cipla Limited. Units affected: 4,438 10x1mL cartons.
Why was this product recalled? ▼
Failed Stability Specifications: Observed OOS results: eg results for colour index
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 10, 2025. Severity: Moderate. Recall number: D-0197-2026.
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