FDAFDA · Food and drugs·Recall number D-1094-2020
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.
Published April 8, 2020 · Recall initiated: March 16, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Defective Container: Recall is due to breaking and shattering of ampules upon opening
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PHYTONADIONE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- Nationwide within the United States
- Lot
- Lot #: ACB902, ACB903, Exp. Date 03/2021; ACB904, Exp. Date 04/2021, ACB905, Exp. Date 06/2021
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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