FDA recall D-0007-2023

Product

Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16

Reason for recall

Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.

Distribution

USA nationwide

Key facts

Status

Completed

Initiation date

2022-09-14

Report date

2022-10-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0007-2023