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.
Reported: April 8, 2020 Initiated: March 16, 2020 #D-1094-2020
Product Description
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
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 10943 cartons
- Distribution
- Nationwide within the United States
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 10943 cartons.
Why was this product recalled? ▼
Defective Container: Recall is due to breaking and shattering of ampules upon opening
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 8, 2020. Severity: Critical. Recall number: D-1094-2020.
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