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FDASeptember 14, 2022drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Completed

Brands named

dr reddy s laboratories

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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