Medications & Supplements/Prescription Drugs

AuroMedics Pharma LLC: Acetaminophen Injection Recalled for Discoloration and Failed pH Levels

Agency Publication Date: February 4, 2021

Summary

AuroMedics Pharma LLC has recalled 3,094 cartons of Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL) due to discoloration and failures in pH specifications. This recall affects single-dose vials used for intravenous administration, which were manufactured in India and distributed nationwide. Consumers should be aware that these quality defects could compromise the stability and safety of the medication.

Risk

The drug failed pH specifications and showed discoloration, which can indicate chemical instability or degradation. Administering an intravenous medication with incorrect pH levels or unidentified degradation products can lead to local site irritation or more serious systemic reactions.

What You Should Do

Check your medication vials and cartons for NDC 55150-307-01 and the specific lot numbers and expiration dates: CAT200002 (exp 9/2022), CAT200004 (exp 9/2022), CAT200005 (exp 9/2022), CAT200008 (exp 9/2022), CAT200009 (exp 9/2022), CAT200013 (exp 10/2022), CAT200014 (exp 10/2022), CAT200015 (exp 10/2022), CAT200016 (exp 10/2022), CAT200017 (exp 10/2022), and CAT200018 (exp 10/2022).
Immediately stop using any vials from the affected lot numbers and quarantine them to prevent further use.
Contact your healthcare provider or pharmacist immediately for guidance if you have recently used or were administered this product and have concerns about your health.
Return any unused vials to the pharmacy or place of purchase for a refund and contact AuroMedics Pharma LLC for further instructions regarding the return process.
For additional questions, 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

Contact healthcare provider and return product to pharmacy.

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

Affected Products

Product: Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial

Model:

NDC 55150-307-01

Recall #: D-0248-2021

Lot Numbers:

CAT200002 (Exp 9/2022)

CAT200004 (Exp 9/2022)

CAT200005 (Exp 9/2022)

CAT200008 (Exp 9/2022)

CAT200009 (Exp 9/2022)

CAT200013 (Exp 10/2022)

CAT200014 (Exp 10/2022)

CAT200015 (Exp 10/2022)

CAT200016 (Exp 10/2022)

CAT200017 (Exp 10/2022)

CAT200018 (Exp 10/2022)

Date Ranges: September 2022, October 2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87067

Status: Resolved

Manufacturer: AuroMedics Pharma LLC

Sold By: AuroMedics Pharma LLC

Manufactured In: India, United States

Units Affected: 3094 cartons

Distributed To: Nationwide

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 · 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

Check your medication vials and cartons for NDC 55150-307-01 and the specific lot numbers and expiration dates: CAT200002 (exp 9/2022), CAT200004 (exp 9/2022), CAT200005 (exp 9/2022), CAT200008 (exp 9/2022), CAT200009 (exp 9/2022), CAT200013 (exp 10/2022), CAT200014 (exp 10/2022), CAT200015 (exp 10/2022), CAT200016 (exp 10/2022), CAT200017 (exp 10/2022), and CAT200018 (exp 10/2022).

Immediately stop using any vials from the affected lot numbers and quarantine them to prevent further use.

Contact your healthcare provider or pharmacist immediately for guidance if you have recently used or were administered this product and have concerns about your health.

Return any unused vials to the pharmacy or place of purchase for a refund and contact AuroMedics Pharma LLC for further instructions regarding the return process.

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

Affected Products

Product: Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial

Model:

NDC 55150-307-01

Recall #: D-0248-2021

Lot Numbers:

CAT200002 (Exp 9/2022)

CAT200004 (Exp 9/2022)

CAT200005 (Exp 9/2022)

CAT200008 (Exp 9/2022)

CAT200009 (Exp 9/2022)

CAT200013 (Exp 10/2022)

CAT200014 (Exp 10/2022)

CAT200015 (Exp 10/2022)

CAT200016 (Exp 10/2022)

CAT200017 (Exp 10/2022)

CAT200018 (Exp 10/2022)

Date Ranges: September 2022, October 2022