Reported Apr 8, 2020 · Terminated
Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose…
Dr. Reddy's Laboratories, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623
Is this the product you have?
- 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
- DistributorDr. Reddy's Laboratories Inc., Princeton, NJ 08540
- Lot codes and dates
Lot #: ACB902ACB903Exp. Date 03/2021ACB904Exp. Date 04/2021ACB905Exp. Date 06/2021
- Amount recalled
- 10943 cartons
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Defective Container: Recall is due to breaking and shattering of ampules upon opening
Using this product could cause serious injury, illness or death — stop using it now.
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