Rasagiline Tablets Recalled Due to Failed Dissolution Specifications
Aurobindo Pharma USA Inc. is recalling Rasagiline 0.5mg tablets for failing dissolution specifications. Patients using this medication should contact their healthcare provider.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall is classified as FDA Class II due to the drug quality failure, but no illnesses or injuries have been reported. The failed dissolution specifications indicate a manufacturing quality issue without documented patient harm.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Rasagiline Tablets 0.5mg, 30-count bottles, distributed nationwide in the United States. The recall involves Lot #3112444 with an expiration date of August 2023. A total of 9,890 bottles have been distributed.
The tablets have failed to meet dissolution specifications. Dissolution testing results were below the average specification level.
This recall affects patients who have received this medication from the recalled lot.
Patients taking this medication from the recalled lot should contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A., NDC 0378-1270-93
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Oral Tablet
- Affected units
- 9,890
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 #: 3112444
- Exp 8/2023
Distribution
Distributed nationwide across the United States.
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