FDA recall D-0013-2016

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.

Reason for recall

Cross Contamination With Other Products: Potential cross-contamination of cephalosporin.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-09-22

Report date

2015-10-21

Termination date

2016-08-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0013-2016