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Recall Observatory FDA recall evidence

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

March 16, 2020

Class I

Product summary

Firm
Dr. Reddy's Laboratories, Inc.
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

    reason.no_named_rule · v1.0.0

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