Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/
Summary
The FDA issued a Class II for Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, by Cipla Limited. Reason: Failed Stability Specifications: Observed OOS results: eg results for colour index.
Details
Source
Drug Recall
External ID
D-0197-2026
Action Date
2025-12-10
Status
Ongoing
Category
drug
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
Lot/Code Info: Batch # PH0072404A, PH0082404A, Exp. Date December 31, 2025
Quantity Affected: 4,438 10x1mL cartons
Reason for Recall
Failed Stability Specifications: Observed OOS results: eg results for colour index
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-31
Company
Pithampur, District Dhar
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 51 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cipla Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cipla Limited have FDA actions?
This is the only FDA action we have on record for Cipla Limited in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0197-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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