Exact FDA event identifier

Event 90545

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, 2022
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Mylan Pharmaceuticals 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens (NDC 49502-394-71), packaged in cartons of 5 prefilled pens (NDC 49502-394-75), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 15317, Manufactured for: Mylan Specialty L.P., Morgantown, WV

D-1292-2022

Recall number: D-1292-2022
Initiated: July 05, 2022
Classification: Class I
Status: Terminated
Recalling firm: Mylan Pharmaceuticals Inc
Quantity: 253,200 pens (50,650/5 per packs)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Missing label: Label missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Missing label: Label missing from some prefilled pens.

Code information

Lot #: BF21002895, Exp. Date Aug 2023

Distribution pattern

Product was distributed nationwide within the United States