D-0159-2023 Class II Terminated
FDA drug recall D-0159-2023 was initiated by Ascend Laboratories, LLC on Dec 28, 2022 and is designated Class II. Reason for recall: Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets. The recall status is terminated (terminated Aug 15, 2024). Affected quantity: 12192 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 25, 2023
- Initiation Date
- Dec 28, 2022
- Termination Date
- Aug 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12192 bottles
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.
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
Code Information
Lot # 22140903. Exp. Dec. 2024
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0159-2023
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026