FDA 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.

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

Key facts

Status

Terminated

Initiation date

2022-12-28

Report date

2023-01-25

Termination date

2024-08-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0159-2023