Product: 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.
Reason for recall: Defective Container: Recall is due to breaking and shattering of ampules upon opening
Recall initiated: 20200316
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated