Why it was recalled
Cross Contamination With Other Products: Potential cross-contamination of cephalosporin.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot Numbers: M51196, M51197, M51198, Exp 01/17
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0013-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 22, 2015
- FDA report date
- Oct 21, 2015
- Quantity
- 164,332 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Midway Importing, Inc
Original FDA data
Every field from FDA enforcement report D-0013-2016, exactly as published.
Show all FDA fields
- City
- Houston
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 72240
- Address
- 1807 Brittmoore Rd
- Code information
- Lot Numbers: M51196, M51197, M51198, Exp 01/17
- Postal code
- 77043-2213
- Report date
- Oct 21, 2015
- Product type
- Drugs
- Recall number
- D-0013-2016
- Classification
- Class II
- Recalling firm
- Midway Importing, Inc
- Product quantity
- 164,332 boxes
- Termination date
- Aug 2, 2016
- Reason for recall
- Cross Contamination With Other Products: Potential cross-contamination of cephalosporin.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 22, 2015
- Initial firm notification
- Letter
- Center classification date
- Oct 13, 2015