Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88647

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

Open FDA event record

Event summary

Timeline bucket
September 09, 2021
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Jacobus Pharmaceutical Company Inc.

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

Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only, Manufactured by: Jacobus Pharmaceutical Company, Inc, P.O. Box 5290, Princeton, New Jersey 08540, NDC 49938-110-01.

D-0008-2022
Recall number
D-0008-2022
Initiated
September 09, 2021
Classification
Class I
Status
Terminated
Quantity
2,324 bottles

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.

Code information

Lot #: 18038, 18039, Exp 03/2023; 18079, Exp 05/2023

Distribution pattern

Product was distributed within the USA and Canada. Control # 18038, was distributed to Canada only.