Ascend Laboratories, LLC: Drug Recall
Recall #D-0159-2023 · 12/28/2022
Class II: Risk
Recall Details
- Recall Number
- D-0159-2023
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Ascend Laboratories, LLC
- Status
- Terminated
- Date Initiated
- 12/28/2022
- Location
- Parsippany, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12192 bottles
Reason for Recall
Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.
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
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
Other Recalls by Ascend Laboratories, LLC
- Class II: Risk 09/19/2025
- Class II: Risk 09/19/2025
- Class II: Risk 09/19/2025
- Class II: Risk 09/19/2025
- Class II: Risk 08/28/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.