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Class III · Lower riskRecall completed

Phytonadione

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot # ACB101, Exp 03/2023
Where it was soldUSA nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byDr.Reddy's Laboratories Inc
Brand namePHYTONADIONE
Generic namePHYTONADIONE
Active ingredient(s)PHYTONADIONE
Distributed by / forDr. Reddy's Laboratories Inc., Princeton, NJ 08540
NDC43598-405-16
Show the full FDA record
Full product labelPhytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16
Recalling firmDr. Reddy's Laboratories, Inc.
DistributionUSA nationwide
Quantity2,838 ampules
Recall initiated2022-09-14
Report date2022-10-12
Recall completed—
Recall numberD-0007-2023
ClassificationClass III
FDA statusCompleted
Origin on filePrinceton NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.