FDA Drug Class III — Least Serious

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

Hazard

Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.

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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
Brand
Dr. Reddy's Laboratories, Inc.
UPC
Lot # ACB101, Exp 03/2023

Units Affected

2,838 ampules

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