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Cipla Limited: Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifescien

DrugsSource: FDA (drug) · Date: 2025-12-10

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Cipla Limited
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
Reason / hazard
Failed Stability Specifications: Observed OOS results: eg results for colour index
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide in the USA
Recall initiated
2025-10-31
Code info
Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025
Product quantity
4,438 10x1mL cartons
Voluntary mandated
Voluntary: Firm initiated
City
Pithampur, District Dhar
Country
India
Event id
97909
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