Shamrock Recalls Mislabelled Sulfamethoxazole and Trimethoprim Tablets
Shamrock Medical Solutions Group LLC is recalling Sulfamethoxazole and Trimethoprim tablets due to a labeling error where 800 mg/160 mg tablets were labeled as 400 mg/80 mg.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Shamrock Medical Solutions Group LLC is recalling Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, Double Strength, prescription (Rx). The recall is due to a labeling error where the product was labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of the correct 800 mg/160 mg strength.
The affected product is identified by Lot 00288N, Use By 9/15/2012, and NDC 53746-272-01. The product was originally manufactured by Amneal/Interpharm and repackaged by Shamrock Medical Solutions in Lewis Center, Ohio. The product was shipped to Colorado, Massachusetts, Ohio, Texas, and Wyoming.
Consumers and healthcare providers should check their inventory for this specific lot and NDC number. If found, the product should be returned to the supplier or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions regarding their medication.
The recalled product
- Product
- SULFAMETHOXAZOLE AND TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM)
- Brand
- SULFAMETHOXAZOLE AND TRIMETHOPRIM
- Manufacturer
- Shamrock Medical Solutions Group LLC
- Category
- Drug — Prescription Medication
- Hazard
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 (3)
- Lot 00288N
- Use By: 9/15/2012
- NDC 53746-272-01
UPCs (2)
- 0353746271013
- 0353746272010
Distribution
Part of a larger recall action
This product is one of 6 recalled by Shamrock Medical Solutions Group LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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