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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92706

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

Open FDA event record

Event summary

Timeline bucket
July 18, 2023
Product types
Drug
Classifications
Class III
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

Fosfomycin Tromethamine Granules for Oral Solution, 3 g single- dose sachet, Rx only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC# 67877-749-57

D-1145-2023
Recall number
D-1145-2023
Initiated
July 18, 2023
Classification
Class III
Status
Terminated
Recalling firm
Ascend Laboratories, LLC
Quantity
99,516 sachets

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.

Code information

Lot #22121970, 22122158, 22121971, 22122189, 22122190, 22122277, 22122278, Exp June 2024; 22122521, 22122522, 22122523, Exp July 2024; 22123328, 22123329, 22123330, Exp September 2024.

Distribution pattern

The recall product was distributed nationwide.