Rasagiline Tablet
FDA Recall NDC 67877-259
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Rasagiline (NDC 67877-259). A significant event, classified as Class II, was initiated on Dec 28, 2022 by Ascend Laboratories, Llc. The reported reason for this action was: "Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
December 2022 Class II Recall: Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
Recall Number
Class II Terminated
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
Dec 28, 2022
Jan 25, 2023
12192 bottles
Recall Profile & Regulatory Data
Event ID
91385
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
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
Termination Date
Aug 15, 2024
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
Batch or Lot Expiration Information
Lot# 22140903. Exp. Dec. 2024
Affected Packages Involved in this Recall
67877-259-30Product
67877-260-30Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
