FDAFDA · Food and drugs·Recall number D-0007-2023
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
Published October 12, 2022 · Recall initiated: September 14, 2022
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PHYTONADIONE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- USA nationwide
- Lot
- Lot # ACB101, Exp 03/2023
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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