Medications & Supplements/Prescription Drugs

Dr. Reddy's Laboratories, Inc.: Phytonadione Injectable Emulsion Recalled for Shattering Glass Ampules

Agency Publication Date: March 27, 2020

Summary

Dr. Reddy's Laboratories is recalling 10,943 cartons of Phytonadione Injectable Emulsion, USP (Vitamin K1), 10 mg/mL. This medication is packaged in 1 mL single-dose glass ampules, which have been found to break or shatter upon opening. This defect can lead to serious injuries from glass shards or compromise the sterility and delivery of the medication. The affected products were distributed nationwide in the United States and are identified by specific lot numbers and expiration dates ranging from March to June 2021.

Risk

The glass ampules can shatter while being opened, posing a risk of lacerations to the user and the potential for glass fragments to contaminate the injectable medication. If contaminated medication is administered, it could cause serious internal injury or infection.

What You Should Do

Immediately check your supply of Phytonadione Injectable Emulsion, USP, 10 mg/mL (1 mL ampules) for the following lot numbers and expiration dates: Lot ACB902 (Exp. 03/2021), Lot ACB903 (Exp. 03/2021), Lot ACB904 (Exp. 04/2021), or Lot ACB905 (Exp. 06/2021).
Look for the National Drug Code (NDC) numbers on the packaging to confirm the product: NDC 43598-405-11 for individual 1 mL ampules or NDC 43598-405-16 for the 25-count cartons.
Stop using the affected medication immediately to avoid the risk of injury from breaking glass.
Contact your healthcare provider or pharmacist for guidance regarding alternative medication and to report the possession of recalled product.
Return any unused product from the affected lots to your pharmacy or the place of purchase for a refund.
Contact Dr. Reddy's Laboratories at their Princeton, NJ location for further instructions regarding the return of these specific lots.
For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Refund for recalled medication.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Phytonadione Injectable Emulsion, USP, 10 mg/mL (1 mL ampule)

Model:

NDC 43598-405-11

NDC 43598-405-16

Lot Numbers:

ACB902 (Exp. 03/2021)

ACB903 (Exp. 03/2021)

ACB904 (Exp. 04/2021)

ACB905 (Exp. 06/2021)

Date Ranges: Exp. Date 03/2021, Exp. Date 04/2021, Exp. Date 06/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85231

Status: Resolved

Manufacturer: Dr. Reddy's Laboratories, Inc.

Sold By: hospitals; pharmacies

Manufactured In: United States

Units Affected: 10943 cartons

Distributed To: Nationwide

Agency Last Updated: April 6, 2020

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Immediately check your supply of Phytonadione Injectable Emulsion, USP, 10 mg/mL (1 mL ampules) for the following lot numbers and expiration dates: Lot ACB902 (Exp. 03/2021), Lot ACB903 (Exp. 03/2021), Lot ACB904 (Exp. 04/2021), or Lot ACB905 (Exp. 06/2021).

Look for the National Drug Code (NDC) numbers on the packaging to confirm the product: NDC 43598-405-11 for individual 1 mL ampules or NDC 43598-405-16 for the 25-count cartons.

Stop using the affected medication immediately to avoid the risk of injury from breaking glass.

Contact your healthcare provider or pharmacist for guidance regarding alternative medication and to report the possession of recalled product.

Return any unused product from the affected lots to your pharmacy or the place of purchase for a refund.

Contact Dr. Reddy's Laboratories at their Princeton, NJ location for further instructions regarding the return of these specific lots.

For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.