September 2017 FDA Recall Drug by Boehringer Ingelheim Pharmaceuticals, Inc.
D-0007-2018 - Labeling

This Class III drug recall was voluntarily initiated by Boehringer Ingelheim Pharmaceuticals, Inc. on September 22, 2017 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed in CO, OH and the recall is currently terminated.

Recall Number: D-0007-2018

Reason for Recall
Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.
Initiated
09-22-2017
Reported
10-18-2017
Quantity
128 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
78172
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Boehringer Ingelheim Pharmaceuticals, 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.
CO, OH
Termination Date About Termination Date
Date that FDA officially terminated the recall.
04-18-2018
Product Description About Product Description
Full technical description of the product.
Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Lic. from: BI Int'l GmbH, Made in Italy, NDC 0597-0030-01

Batch or Lot Expiration Information

Lot# Lot 754037