December 2020 FDA Recall Acetaminophen by Auromedics Pharma Llc
D-0248-2021 - Discoloration and failed pH specifications

This Class II drug recall was voluntarily initiated by Auromedics Pharma Llc on December 30, 2020 for the product Acetaminophen. The FDA reported the reason for recall as discoloration and failed ph specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0248-2021

Reason for Recall
Discoloration and failed pH specifications
Initiated
12-30-2020
Reported
02-10-2021
Quantity
3094 cartons

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87067
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
AuroMedics Pharma LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-19-2023
Product Description About Product Description
Full technical description of the product.
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

55150-307-01 Acetaminophen
55150-307-24 Acetaminophen