FDA-Drug2022-10-12Class III
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
Dr. Reddy's Laboratories, Inc.
Hazard
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Sold states
USA nationwide
Affected count
2,838 ampules
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0007-2023Don't want to check this manually?
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