Exact FDA event identifier

Event 81765

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

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Event summary

Timeline bucket: December 07, 2018
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Sun Pharmaceutical Industries, 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

Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Research Inc. Humacao, PR 00792, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, UPC 310631117313, NDC 10631-117-31 (carton) NDC10631-117-69 (prescription pack)

D-1207-2019

Recall number: D-1207-2019
Initiated: December 07, 2018
Classification: Class III
Status: Terminated
Recalling firm: Sun Pharmaceutical Industries, Inc.
Quantity: 47,520 prescription packs

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: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.

Code information

Lot: 17F28AA, Exp 1/2020

Distribution pattern

Nationwide in the USA