September 2022 FDA Recall Phytonadione by Dr. Reddy's Laboratories, Inc.
D-0007-2023 - Failed Stability Specifications
This Class III drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on September 14, 2022 for the product Phytonadione. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-0007-2023
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
09-14-2022
10-12-2022
2,838 ampules
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
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.
USA nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
