December 2017 FDA Recall Drug by Solco Healtcare Us Llc
D-0155-2018 - Labeling

This Class II drug recall was voluntarily initiated by Solco Healtcare Us Llc on December 4, 2017 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in Product was distributed in Mason, OH. and the recall is currently terminated.

Recall Number: D-0155-2018

Reason for Recall
Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg
Initiated
12-04-2017
Reported
01-17-2018
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78697
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.
Solco Healtcare US 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.
Product was distributed in Mason, OH.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-25-2019
Product Description About Product Description
Full technical description of the product.
Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcare US, LLC, Cranbury, NJ, 08512, USA. NDC 43547-0333-50

Batch or Lot Expiration Information

Lot# 7700656A