Rizatriptan Benzoate Tablets Recall Due to Out-of-Specification Impurities
MacLeods Pharma USA is recalling Rizatriptan Benzoate Film Coated Tablets (10 mg) due to out-of-specification test results in organic impurities testing. The recall affects multiple lot numbers distributed nationwide.
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 III recall with out-of-specification impurities detected during quality control testing but no reported illnesses or injuries. Per the severity rubric, Class III recalls are typically scored 1 or 2. The out-of-specification test result is a manufacturing/quality issue rather than an active hazard with confirmed patient harm, supporting a Moderate (2) designation.
Plain-English summary
MacLeods Pharma USA, Inc. is recalling Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in 12-tablet and 18-tablet blister packs. The recall was initiated due to out-of-specification test results obtained during organic impurities testing of controlled samples.
The affected product includes approximately 135,082 blister packs containing 2,431,476 tablets. Lot numbers BRJ2112A, BRJ2113A, BRJ2114A, and BRJ2114B with an expiration date of 04/2024 are included in this recall. The product was distributed nationwide within the United States.
Patients currently taking affected tablets should consult their healthcare provider before discontinuing use or making any changes to their medication regimen. Healthcare providers and patients with questions about this recall should contact MacLeods Pharma USA, Inc. The FDA is monitoring this recall.
The recalled product
- Product
- RIZATRIPTAN (RIZATRIPTAN)
- Brand
- RIZATRIPTAN
- Manufacturer
- MACLEODS PHARMA USA, INC
- Hazard
- out-of-specification-impurities
- organic-impurities
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 (5)
- Lot #: BRJ2112A
- BRJ2113A
- BRJ2114A
- BRJ2114B
- exp. date 04/2024
UPCs (4)
- 0333342088468
- 0333342087072
- 0333342088079
- 0333342087461
Distribution
Distributed nationwide across the United States.
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