Recall: D-1094-2020

Class I - Dangerous

Class IClassification

2020-03-16Initiated

TerminatedStatus

Dr. Reddy's Laboratories, Inc.Firm

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

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

Distribution

Nationwide within the United States

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.