January 2018 FDA Recall Ampicillin And Sulbactam by Aurobindo Pharma Ltd.
D-0339-2018 - Presence of Particulate Matter

This Class I drug recall was voluntarily initiated by Aurobindo Pharma Ltd. on January 2, 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-0339-2018

Reason for Recall
Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
Initiated
01-02-2018
Reported
02-14-2018
Quantity
53,040 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78847
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.
Aurobindo Pharma Ltd.
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.
distributed nationwide in the USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-10-2019
Product Description About Product Description
Full technical description of the product.
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

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