September 2015 FDA Recall Drug by Midway Importing, Inc
D-0013-2016 - Cross Contamination With Other Products

This Class II drug recall was voluntarily initiated by Midway Importing, Inc on September 22, 2015 for the product Drug. The FDA reported the reason for recall as cross contamination with other products. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0013-2016

Reason for Recall
Cross Contamination With Other Products: Potential cross-contamination of cephalosporin.
Initiated
09-22-2015
Reported
10-21-2015
Quantity
164,332 boxes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72240
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.
Midway Importing, 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.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-02-2016
Product Description About Product Description
Full technical description of the product.
Sedalmex (Acetaminophen 500 mg with Caffeine 65 mg) Pain Reliever tablets, 20-count tablets in blisters per box, Manufactured in Mexico by: Merck, S.A. de C.V./, Imported & Distributed by Midway Importing, Inc., 1807 Brittmoore Rd, Houston, TX 77043, UPC: 1 88436 00017 4.

Batch or Lot Expiration Information

Lot# Lot Numbers: M51196, M51197, M51198, Exp 01/17