August 2017 FDA Recall Drug by Amneal Pharmaceuticals Llc
D-0076-2018 - Presence of Particulate Matter

This Class II drug recall was voluntarily initiated by Amneal Pharmaceuticals Llc on August 31, 2017 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed in MS, NC, OH, TX, UT and the recall is currently terminated.

Recall Number: D-0076-2018

Reason for Recall
Presence of Particulate Matter
Initiated
08-31-2017
Reported
11-22-2017
Quantity
14,000 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78035
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.
Amneal Pharmaceuticals 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.
MS, NC, OH, TX, UT
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.
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7

Batch or Lot Expiration Information

Lot# AP160016; Exp. 05/18