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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92366

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

Open FDA event record

Event summary

Timeline bucket
May 25, 2023
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Viatris 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

Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only, Distributed by: Meda pharmaceuticals Inc. (a Viatris company) Somerset New Jersey 00873-4120, NDC #0037-9001-05

D-0866-2023
Recall number
D-0866-2023
Initiated
May 25, 2023
Classification
Class II
Status
Terminated
Recalling firm
Viatris Inc
Quantity
2,736 boxes

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Code information

Lot #: 101241A, Exp 10/23

Distribution pattern

Product was distributed to 10 distributors who may have further distribute the product to the retail level.