Recall: D-0159-2023

Class II - Potentially Harmful

Class IIClassification

2022-12-28Initiated

TerminatedStatus

Ascend Laboratories, LLCFirm

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

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

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.