Ampicillin And Sulbactam Injection, Powder, For Solution
FDA Recall NDC 55150-178
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Ampicillin And Sulbactam (NDC 55150-178). A significant event, classified as Class I, was initiated on May 01, 2018 by Eugia Us Llc. The reported reason for this action was: "Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients."
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 I Terminated
Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
May 01, 2018
May 16, 2018
54,720 vials
Recall Profile & Regulatory Data
Event ID
79996
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
AuroMedics Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Nov 06, 2024
Product Description
Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ, NDC 55150-117-20.
Batch or Lot Expiration Information
Lot# : AS0317041-A, AS0317035-A; Exp August 2019
Affected Packages Involved in this Recall
55150-116-20Product
55150-117-20Product
55150-178-99Product
55150-179-99Product
Class I Terminated
Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
Jan 02, 2018
Feb 14, 2018
53,040 vials
Recall Profile & Regulatory Data
Event ID
78847
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Aurobindo Pharma Ltd.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
distributed nationwide in the USA
Termination Date
Sep 10, 2019
Product Description
Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed by AuroMedics Pharma LLC. 279 Princeton-Highstown Rd. E. Windsor, NJ 08520, NDC 55150-116-20
Batch or Lot Expiration Information
Lot# Lot Number AF0117001-A
Affected Packages Involved in this Recall
55150-116-20Product
55150-117-20Product
55150-178-99Product
55150-179-99Product
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.
