Dr. Reddy's Laboratories, Inc. recalls Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Re
Recalled October 12, 2022 · FDA recall D-0007-2023 · Dr. Reddy's Laboratories
Hazard
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content. · FDA Class III
Units
2,838 ampules
Sold at
USA nationwide
Description
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
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
Manufacturer(s)
Dr. Reddy's Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →