Sedalmex Pain Reliever Tablets Recalled for Potential Cephalosporin Contamination
Midway Importing, Inc. is recalling Sedalmex pain reliever tablets due to potential cross-contamination with cephalosporin. Consumers should stop using the product and return it to the point of purchase.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a drug product with a potential cross-contamination hazard (cephalosporin) where no specific injuries or illnesses are reported in the source text, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Midway Importing, Inc. is recalling Sedalmex (Acetaminophen 500 mg with Caffeine 65 mg) Pain Reliever tablets. The recall is being conducted due to potential cross-contamination with cephalosporin. The affected product consists of 20-count tablets in blisters per box, manufactured in Mexico by Merck, S.A. de C.V. and imported and distributed by Midway Importing, Inc. in Houston, Texas.
The recall covers 164,332 boxes distributed nationwide. The specific lot numbers affected are M51196, M51197, and M51198, all with an expiration date of 01/17. The product can be identified by the UPC 1 88436 00017 4.
Consumers who have purchased these specific lot numbers should stop using the product immediately. They should return the product to the place of purchase for a refund or contact Midway Importing, Inc. for further instructions.
The recalled product
- 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.
- Manufacturer
- Midway Importing, Inc
- Category
- Drug — Pain Reliever
- Affected units
- 164,332
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot Numbers: M51196
- M51197
- M51198
- Exp 01/17
Distribution
Distributed nationwide across the United States.
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