Candesartan Cilexetil tablets recalled for impurity specification failure
Viatris is recalling Candesartan Cilexetil Tablets, USP 16 mg due to failed impurities and degradation specifications. One lot distributed nationwide does not meet required purity standards.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall for a specification failure (impurity/degradation) with no reported illnesses or injuries. The source text does not indicate the out-of-specification impurity poses direct safety risk or that patient harm has occurred. Per the rubric, Class III recalls without reported injury are typically scored 1 or 2.
Plain-English summary
Viatris is recalling Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles (NDC 0378-3231-93) due to failed impurities and degradation specifications. The affected product was found to be out of specification for Related Compound, meaning it does not meet FDA-required purity standards.
The recalled lot is Lot # 3107334 with an expiration date of October 2021. The product was manufactured for Mylan Pharmaceuticals Inc. and distributed nationwide. Approximately 21,094 units were affected.
Patients taking this medication should not stop taking their blood pressure medication without consulting their healthcare provider. Those with questions or who have this product should contact their pharmacist or physician for guidance on replacement medication.
The recalled product
- Product
- CANDESARTAN CILEXETIL (CANDESARTAN CILEXETIL)
- Brand
- CANDESARTAN CILEXETIL
- Manufacturer
- Viatris
- Hazard
- impurity-specification-failure
- out-of-specification-degradation
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)
- Lot # 3107334
- exp. date October 2021
UPCs (3)
- 0303783232935
- 0303783225937
- 0303783224930
Distribution
Distributed nationwide across the United States.
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