Drug recall D-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
Reason for recall
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
Lots and codes
Lot # 22140903. Exp. Dec. 2024
Recall details
- Recalling firm
- Ascend Laboratories, LLC, Parsippany, NJ
- Quantity
- 12192 bottles
- Distribution
- 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
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 28, 2022
- Terminated
- August 15, 2024
Related products
- Rasagiline – drug information
- NDC 67877-260 Rasagiline · Rasagiline Mesylate 1 mg/1 · Ascend Laboratories, LLC
- NDC 67877-259 Rasagiline · Rasagiline Mesylate .5 mg/1 · Ascend Laboratories, LLC