December 2017 FDA Recall Drug by Amneal Pharmaceuticals
D-0610-2018 - Presence of particulate matter
This Class II drug recall was voluntarily initiated by Amneal Pharmaceuticals on December 15, 2017 for the product Drug. 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-0610-2018
Presence of particulate matter
12-15-2017
04-04-2018
12,584 vials
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Amneal Pharmaceuticals
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S.A Nationwide
08-03-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1
Batch or Lot Expiration Information
Lot# : AP160022, AP160023, Exp. 05/2018; AP16038, AP160039, AP160040, Exp. 06/2018; AP160076, AP160077, AP160078, Exp. 12/2018
