Home / Recalls / Ascend Laboratories, LLC / D-0159-2023

D-0159-2023 Class II Terminated

Recalled by Ascend Laboratories, LLC — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
January 25, 2023
Initiation Date
December 28, 2022
Termination Date
August 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

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  • D-0019-2026 Class II — Atorvastatin Calcium Tablets USP, 20 mg, Rx Only, a). 90-count(NDC 67877-512-90) (September 19, 2025)
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  • D-0469-2025 Class II — Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx On (May 23, 2025)