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.
Recall initiated: 20220914
Status: Completed
Classification: Class III
Recall type: Voluntary: Firm initiated