Rasagiline Tablets Recalled for Foreign Particle Contamination
Ascend Laboratories is recalling Rasagiline Mesylate Tablets 1 mg due to black spots and metallic specks on tablets. The recall affects 12,192 bottles distributed to customers in 19 states and Puerto Rico.
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 Class II recall involves contamination of a pharmaceutical product with foreign material. No illnesses or injuries have been reported. The presence of foreign particles in medication represents a risk of harm due to potential ingestion or adverse effects.
Plain-English summary
Ascend Laboratories, LLC is recalling Rasagiline Mesylate Tablets 1 mg (NDC 67877-260-30) because tablets were found to contain black spots and shiny metallic specks, indicating foreign material contamination. The affected product is Lot 22140903, which expires December 2024.
The recalled tablets were distributed to customers in California, Florida, Georgia, Illinois, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Washington, Wisconsin, and Puerto Rico. A total of 12,192 bottles were distributed.
Patients taking Rasagiline who have the recalled product should contact their healthcare provider to discuss next steps. Pharmacy records can be checked using the lot number and expiration date to identify affected prescriptions. Report any adverse events related to this product to the FDA or Ascend Laboratories.
The recalled product
- Product
- RASAGILINE (RASAGILINE)
- Brand
- RASAGILINE
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Oral Tablet
- Affected units
- 12,192
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 (1)
- Lot # 22140903. Exp. Dec. 2024
UPCs (1)
- 0367877260303
Distribution
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