March 2020 FDA Recall Drug by Mayne Pharma Inc
D-0998-2020 - Product Mix-Up

This Class II drug recall was voluntarily initiated by Mayne Pharma Inc on March 2, 2020 for the product Drug. The FDA reported the reason for recall as product mix-up. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0998-2020

Reason for Recall
Product Mix-Up: A foreign tablet was found in bottle.
Initiated
03-02-2020
Reported
03-18-2020
Quantity
8274 100-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85125
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.
Mayne Pharma Inc
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.
10-28-2021
Product Description About Product Description
Full technical description of the product.
Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne Pharma, Greenville, NC 27834. NDC 51862-858-01

Batch or Lot Expiration Information

Lot# Lot: FG11514 Exp. 05/2021