FDAClass IIJuly 30, 2014

Sulfamethoxazole and Trimethoprim Tablets recall: Labeling Error

Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim…

Why was Sulfamethoxazole and Trimethoprim Tablets recalled?

Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 00288N, Use By: 9/15/2012, NDC 53746-272-01

Product
Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim…
Recalling firm
Shamrock Medical Solutions Group LLC
Quantity
284/800 mg tablets
Distribution
Product was shipped to the following states: CO, MA, OH, TX & WY.
Recall date
July 30, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls