Drug 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
D-0197-2026
Product summary
- Firm
- Cipla Limited
- Event
- Event 97909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,438 10x1mL cartons
- Official record key
drug-enforcement:D-0197-2026
Official wording
Reason: Failed Stability Specifications: Observed OOS results: eg results for colour index
Code information: Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications