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

FDA recall notice · announced January 25, 2023 · Ascend Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Presence of Foreign Substance- A complaint was received of black spots/shiny metallic speck on the tablets.

Notes

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
Lot/code information: Lot # 22140903. Exp. Dec. 2024
Quantity: 12192 bottles
Status: Terminated
Products in this recall event:
- 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 (D-0159-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.