Recalls / Class III
Class IIID-0007-2023
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
- Brand name
- Phytonadione
- Generic name
- Phytonadione
- Active ingredient
- Phytonadione
- Route
- Intramuscular, Intravenous, Subcutaneous
- NDC
- 43598-405
- FDA application
- ANDA207719
- Affected lot / code info
- Lot # ACB101, Exp 03/2023
Why it was recalled
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr.Reddy's Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 2,838 ampules
- Distribution pattern
- USA nationwide
Timeline
- Recall initiated
- 2022-09-14
- FDA classified
- 2022-10-06
- Posted by FDA
- 2022-10-12
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0007-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.