Drug 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
D-0159-2023
Product summary
- Event
- Event 91385
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12192 bottles
- Official record key
drug-enforcement:D-0159-2023
Official wording
Reason: Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
Code information: Lot # 22140903. Exp. Dec. 2024
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
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance