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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91385

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
December 28, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Ascend Laboratories, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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
Recall number
D-0159-2023
Initiated
December 28, 2022
Classification
Class II
Status
Terminated
Recalling firm
Ascend Laboratories, LLC
Quantity
12192 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Foreign Substance

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot # 22140903. Exp. Dec. 2024

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