Class I
Terminated
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.
This recall has been terminated (originally issued April 8, 2020).
- Company
- Dr. Reddy'S Laboratories, Inc.
- Recall Initiated
- March 16, 2020
- Posted
- April 8, 2020
- Recall Number
- D-1094-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 10943 cartons
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Defective Container: Recall is due to breaking and shattering of ampules upon opening
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: ACB902, ACB903, Exp. Date 03/2021; ACB904, Exp. Date 04/2021, ACB905, Exp. Date 06/2021
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