FDA Recall D-1094-2020

Dr. Reddy's Laboratories, Inc. · Princeton, NJ

Class I — life-threatening Terminated 1011 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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.

Lot / code: Lot #: ACB902, ACB903, Exp. Date 03/2021; ACB904, Exp. Date 04/2021, ACB905, Exp. Date 06/2021

Quantity: 10943 cartons

Reason for recall

Defective Container: Recall is due to breaking and shattering of ampules upon opening

Recall record

Recall number: D-1094-2020
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2020-03-16
Classified by FDA Center: 2020-04-06
FDA published: 2020-04-08
Terminated: 2022-12-22
Recalling firm: Dr. Reddy's Laboratories, Inc.
Firm location: Princeton, NJ

Drug identification

Brand name(s): PHYTONADIONE
Generic name(s): PHYTONADIONE
Manufacturer(s): Dr.Reddy's Laboratories Inc
NDC(s): 43598-405
Route(s): INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

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