Phytonadione Injection, Emulsion
FDA Recall NDC 43598-405
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Phytonadione (NDC 43598-405). A significant event, classified as Class III, was initiated on Sep 14, 2022 by Dr.reddy's Laboratories Inc. The reported reason for this action was: "Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Completed
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Sep 14, 2022
Oct 12, 2022
2,838 ampules
Recall Profile & Regulatory Data
Event ID
90868
Classification
Class III
Enforcement Status
Completed
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide
Product Description
Phytonadione 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
Batch or Lot Expiration Information
Lot# ACB101, Exp 03/2023
Affected Packages Involved in this Recall
43598-405-11Product
43598-405-16Product
Class I Terminated
Defective Container: Recall is due to breaking and shattering of ampules upon opening
Mar 16, 2020
Apr 08, 2020
10943 cartons
Recall Profile & Regulatory Data
Event ID
85231
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Dec 22, 2022
Product Description
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
Affected Packages Involved in this Recall
43598-405-11Product
43598-405-16Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
