FDA-Drug2020-04-08Class I
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.
Dr. Reddy's Laboratories, Inc.
Hazard
Defective Container: Recall is due to breaking and shattering of ampules upon opening
Sold states
Nationwide within the United States
Affected count
10943 cartons
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1094-2020Don't want to check this manually?
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