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
Recall Number: D-0007-2023
Firm: Dr. Reddy's Laboratories, Inc.
Classification: Class III
Status: Completed
Report Date: 20221012
Initiation Date: 20220914
Termination Date:
Reason for Recall
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Product Description
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