Dr. Reddy’s Laboratories Ltd. (along with its subsidiaries together referred to as “Dr. Reddy’s”) announced today that it is voluntarily recalling four lots (ACB902, ACB903, ACB904, ACB905) of Phytonadione Injectable Emulsion USP, 10 mg/mL, Single-Dose Ampules to the hospital level. The product is being recalled due to product complaints received due to ampules breaking and shattering, upon opening, during compounding.
The company has received reports of cuts in skin and lacerations to health care professionals. There may be a reasonable probability of flying glass injuring skin, eye and/or other parts which could result in either temporary or permanent injury.
Phytonadione injectable emulsion, is indicated in the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by Vitamin K deficiency or interference with Vitamin K activity.
Phytonadione injectable emulsion is indicated in anticoagulant-induced prothrombin deficiency caused by coumarin or indanedione derivatives; prophylaxis and therapy of hemorrhagic disease of the newborn; hypoprothrombinemia due to antibacterial therapy; hypoprothrombinemia secondary to factors limiting absorption or synthesis of Vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancreas, and regional enteritis; other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with phytonadione metabolism, e.g., salicylates.
The product is packaged in a carton with 25 X 1 mL Single-Dose Ampules. The batches were distributed nationwide, in U.S. only, between June 21, 2019 and February 26, 2020, to wholesalers, distributors, hospitals and pharmacies.
The recalled lot details are as follows :
|
Item Description |
Lot Number |
Expiration date |
NDC Number |
|
Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules. |
ACB902 |
03/2021 |
43598-405-16 |
|
Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules. |
ACB903 |
03/2021 |
43598-405-16 |
|
Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules. |
ACB904 |
04/2021 |
43598-405-16 |
|
Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules. |
ACB905 |
06/2021 |
43598-405-16 |
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
