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Dr. Reddy's Laboratories, Inc. recalls Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules

Recalled April 8, 2020 · FDA recall D-1094-2020 · Dr. Reddy's Laboratories

Hazard
Defective Container: Recall is due to breaking and shattering of ampules upon opening · FDA Class I
Units
10943 cartons
Sold at
Nationwide within the United States

Description

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

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.
Manufacturer(s)
Dr. Reddy's Laboratories, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Dr. Reddy's Laboratories, Inc. recalls Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules | RecallWatchUSA