Exact FDA event identifier

Event 71765

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

Event summary

Timeline bucket: July 13, 2015
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Perrigo Israel Pharmaceuticals

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

Mometasone Furoate Ointment USP, 0.1%, 15 g tubes, Rx Only, Manufactured by Perrigo, Yeruham 80500, Israel, Distributed by Perrigo, Allegan, MI 49010, NDC 45802-0119-37

D-1286-2015

Recall number: D-1286-2015
Initiated: July 13, 2015
Classification: Class III
Status: Terminated
Recalling firm: Perrigo Israel Pharmaceuticals
Quantity: 158,268 tubes

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent drug

Code information

Lot # 063630, Exp 04/16; 069793, Exp 11/16; 071745, Exp 02/17; 076150, Exp 07/17; 081317, Exp 12/17

Distribution pattern

Nationwide and Puerto Rico