Recalls / Class II
Class IID-0159-2023
Product
Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactured by Alkem Laboratories Ltd., India; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054
- Brand name
- Rasagiline
- Generic name
- Rasagiline
- Active ingredient
- Rasagiline Mesylate
- Route
- Oral
- NDCs
- 67877-259, 67877-260
- FDA application
- ANDA201889
- Affected lot / code info
- Lot # 22140903. Exp. Dec. 2024
Why it was recalled
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
Recalling firm
- Firm
- Ascend Laboratories, LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 339 Jefferson Rd Ste 101, N/A, Parsippany, New Jersey 07054-3707
Distribution
- Quantity
- 12192 bottles
- Distribution pattern
- Customers in 19 states: CA, FL, GA, IL, KY, LA, MI, MN, MS, NC, NJ, NY, OH, PA, RI, TN, TX, WA, WI; Puerto Rico
Timeline
- Recall initiated
- 2022-12-28
- FDA classified
- 2023-01-16
- Posted by FDA
- 2023-01-25
- Terminated
- 2024-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0159-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.