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
Failed Stability Specifications: Observed OOS results: eg results for colour index…
From the FDA notice · Read the official notice ↗ · All Cipla recalls
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- 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
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 4,438 10x1mL cartons
- Illnesses reported
- None reported
- Manufactured in
- Plot No. 9 & 10, Pharma Zone Phase Ii, Section Iiii, Indore Special Economic Zone, Pithampur, District Dhar, India
- Classification
- Class II
- Recall number
- D-0197-2026
In the FDA's words
- 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 Failed Stability Specifications: Observed OOS results: eg results for colour index Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025 Distribution: Nationwide in the USA Affected quantity: 4,438 10x1mL cartons
- Hazard
- Failed Stability Specifications: Observed OOS results: eg results for colour index