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FDAMarch 16, 2020drug

Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules per carton (NDC 43598-405-16); Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540.

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

The hazard

Defective Container: Recall is due to breaking and shattering of ampules upon opening

What to do

FDA enforcement status: Terminated

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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