December 2022 FDA Recall Rasagiline by Ascend Laboratories, Llc
D-0159-2023 - Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.

This Class II drug recall was voluntarily initiated by Ascend Laboratories, Llc on December 28, 2022 for the product Rasagiline. The FDA reported the reason for recall as presence of foreign substance- a complaint was received of black spots/shiny metallic speck on the tablets.. The product was distributed in 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 and the recall is currently terminated.

Recall Number: D-0159-2023

Reason for Recall
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
Initiated
12-28-2022
Reported
01-25-2023
Quantity
12192 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
91385
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Ascend Laboratories, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial 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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2024
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 22140903. Exp. Dec. 2024

Affected Packages Involved in this Recall

67877-259-30 Rasagiline
67877-260-30 Rasagiline