Ezetimibe and Simvastatin Tablets Recalled for Excipient Specification Failure
Golden State Medical Supply Inc. is recalling Ezetimibe and Simvastatin 10 mg/80 mg tablets because the product was manufactured using an excipient that failed conductivity specifications.
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: This is an FDA Class II recall involving a manufacturing defect (out-of-specification excipient). No reported illnesses, injuries, or hospitalization are stated in the source, and the hazard is a specification failure rather than a known safety threat. This meets the criteria for a Moderate severity recall.
Plain-English summary
Golden State Medical Supply Inc. is recalling Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, in 500-tablet bottles (NDC 51407-193-05, lot GS040048, expiration 1/2023). The recall was initiated because the product was manufactured using an excipient found to be out of specification for conductivity.
The affected product was distributed to two distributors located in Arizona and Missouri. A total of 49 units were involved in this distribution.
Patients currently taking this medication should consult their healthcare provider before making any changes to their treatment. Healthcare providers and patients who have this product should stop using it and contact Golden State Medical Supply Inc. for further instructions.
The recalled product
- Product
- EZETIMIBE AND SIMVASTATIN (EZETIMIBE AND SIMVASTATIN)
- Brand
- EZETIMIBE AND SIMVASTATIN
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug — Prescription Tablets
- Hazard
- excipient-specification-failure
- manufacturing-defect
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 (2)
- GS040048
- Exp: 1/2023
Distribution
Distributed in 2 states:
- AZ
- MO
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