Rasagiline Mesylate Tablets 1 mg; 30 tablets in HDPE bottle; Rx only; NDC 67877-260-30; Manufactu...
FDA Recall #D-0159-2023 — Class II — December 28, 2022
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
Reason for Recall
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
Recalling Firm
Ascend Laboratories, LLC — Parsippany, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product 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
Code Information
Lot # 22140903. Exp. Dec. 2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated