FDA recall D-1094-2020

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

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2020-03-16

Report date

2020-04-08

Termination date

2022-12-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1094-2020