Class III Recall

Dr. Reddy's Laboratories, Inc.

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
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Classification
Class III
Status
Completed
Lot
Lot # ACB101, Exp 03/2023
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.