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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80387

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

Open FDA event record

Event summary

Timeline bucket
July 05, 2018
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Sanofi-Aventis U.S. 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

Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0024-5925-00

D-0925-2018
Recall number
D-0925-2018
Initiated
July 05, 2018
Classification
Class II
Status
Ongoing
Recalling firm
Sanofi-Aventis U.S. LLC
Quantity
3214 prefilled pens

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.

Code information

Lot #: 7F021B, Exp 6/30/20

Distribution pattern

Nationwide