Status
Terminated
Drug Enforcement D-0159-2023
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
Classification
Class II
Report Date
January 25, 2023
Termination Date
August 15, 2024
Product Information
- Product description
- 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
- Product quantity
- 12192 bottles
- Reason for recall
- Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
- Recall initiation reason
- —
- Initial firm notification
- 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
Location & Firm
- Recalling firm
- Ascend Laboratories, LLC
- Address
-
339 Jefferson Rd Ste 101, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0159-2023
- Event ID
- 91385
- Recall initiation date
- December 28, 2022
- Center classification date
- January 16, 2023
- Code info
- Lot # 22140903. Exp. Dec. 2024
- More code info
- —