Acetaminophen Injection, Solution
FDA Recall NDC 55150-307
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Acetaminophen (NDC 55150-307). A significant event, classified as Class II, was initiated on Dec 30, 2020 by Eugia Us Llc. The reported reason for this action was: "Discoloration and failed pH specifications"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Discoloration and failed pH specifications
Dec 30, 2020
Feb 10, 2021
3094 cartons
Recall Profile & Regulatory Data
Event ID
87067
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
AuroMedics Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 19, 2023
Product Description
Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, For Intravenous Use Only, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Made in India NDC 55150-307-01
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
55150-307-01Product
55150-307-24Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
