May 2018 FDA Recall Ampicillin And Sulbactam by Auromedics Pharma Llc
D-0866-2018 - Presence of Particulate Matter

This Class I drug recall was voluntarily initiated by Auromedics Pharma Llc on May 1, 2018 for the product Ampicillin And Sulbactam. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0866-2018

Reason for Recall
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.
Initiated
05-01-2018
Reported
05-16-2018
Quantity
54,720 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
79996
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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 in the USA and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-06-2024
Product Description About Product Description
Full technical description of the product.
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

55150-116-20 Ampicillin And Sulbactam
55150-117-20 Ampicillin And Sulbactam
55150-178-99 Ampicillin And Sulbactam
55150-179-99 Ampicillin And Sulbactam