March 2020 FDA Recall Phytonadione by Dr. Reddy's Laboratories, Inc.
D-1094-2020 - Defective Container
This Class I drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on March 16, 2020 for the product Phytonadione. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1094-2020
Defective Container: Recall is due to breaking and shattering of ampules upon opening
03-16-2020
04-08-2020
10943 cartons
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
12-22-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# : ACB902, ACB903, Exp. Date 03/2021; ACB904, Exp. Date 04/2021, ACB905, Exp. Date 06/2021
