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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84073

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

Open FDA event record

Event summary

Timeline bucket
October 16, 2019
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Amneal 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

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

Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3

D-0321-2020
Recall number
D-0321-2020
Initiated
October 16, 2019
Classification
Class III
Status
Terminated
Quantity
2460 cartons/3 blister cards/10 capsules each

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.

Code information

Batch Numbers: BL10917, BL11017, BL11117, Exp. date 11/2019

Distribution pattern

Recalled product was distributed to retailers and wholesalers who may have further distribute the product.