Drug 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.
D-1094-2020
Product summary
- Event
- Event 85231
- Status
- Terminated
- Classification
- Class I
- Quantity
- 10943 cartons
- Official record key
drug-enforcement:D-1094-2020
Official wording
Reason: Defective Container: Recall is due to breaking and shattering of ampules upon opening
Code information: Lot #: ACB902, ACB903, Exp. Date 03/2021; ACB904, Exp. Date 04/2021, ACB905, Exp. Date 06/2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Unknown
Defective Container: Recall is due to breaking and shattering of ampules upon opening