Dr. Reddy’s Laboratories announced the voluntary recall of 4 lots of Phytonadione Injectable Emulsion 10mg/mL single-dose ampules to the hospital level due to ampules breaking and shattering, upon opening, during compounding.
The 4 recalled lots of Phytonadione Injectable Emulsion 10 mg/mL single-dose ampules, NDC# 43598-405-16 were distributed nationwide, in the US only, between June 21, 2019 and February 26, 2020, to wholesalers, distributors, hospitals and pharmacies. The recalled lots include the following:
- Lot Number: ACB902; Expiration Date 03/2021.
- Lot Number: ACB903; Expiration Date 03/2021.
- Lot Number: ACB904; Expiration Date 04/2021.
- Lot Number: ACB905; Expiration Date 06/2021.
Phytonadione Injectable is indicated for the treatment of several 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.
The product is approved for 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 (eg, 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 (eg, salicylates).
According to the Company, healthcare professionals have reported cuts and lacerations to the skin after attempting to open the recalled product and that “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.”
Any adverse events associated with the recall should be reported to the FDA’s MedWatch program.
For more information regarding this recall contact Dr. Reddy’s Laboratories, by calling (888) 375-3784 or visit drreddys.com.