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 07

Recall Summary Cipla USA is recalling Phytonadione Injectable Emulsion 10mg/mL (a vitamin K medication) distributed nationwide because the product failed stability testing, including tests for color appearance. This is a Class I recall, meaning the medication could cause serious harm or death. The affected product comes in 10-vial cartons with specific NDC numbers (69097-708-31 and 69097-708-96).

Recalling firm

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

Failed Stability Specifications: Observed OOS results: eg results for colour index

Classification

Class I

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2025-10-31

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

Nationwide in the USA

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/f9c5d6c9-a07c-4abc-a858-c0e5536ac2d0