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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77760

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

Open FDA event record

Event summary

Timeline bucket
May 11, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
AtHome Medical, 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

Oxygen Refrigerated Liquid USP UN 1073, Rx only, At Home Medical 200 American Road, Morris Plains, NJ 07950,973-538-0485.

D-1060-2017
Recall number
D-1060-2017
Initiated
May 11, 2017
Classification
Class II
Status
Terminated
Recalling firm
AtHome Medical, Inc.
Quantity
80 lbs

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
GMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GMP Deviations: The firm does not include an SOP for testing for out of specifications.

Code information

B-06324027 (AHM #E040645) Lot #: 051017V1, Exp. Date: 5/11/17

Distribution pattern

NJ