Drug recall D-1094-2020
Product
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.
Reason for recall
Defective Container: Recall is due to breaking and shattering of ampules upon opening
Lots and codes
Lot #: ACB902, ACB903, Exp. Date 03/2021; ACB904, Exp. Date 04/2021, ACB905, Exp. Date 06/2021
Recall details
- Recalling firm
- Dr. Reddy's Laboratories, Inc., Princeton, NJ
- Quantity
- 10943 cartons
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 16, 2020
- Terminated
- December 22, 2022
Related products
- Phytonadione – drug information
- NDC 43598-405 Phytonadione Phytonadione · Phytonadione 10 mg/mL · Dr.Reddy's Laboratories Inc