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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81914

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

Open FDA event record

Event summary

Timeline bucket
January 11, 2019
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Oxalis Labs

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

Clobetasol Propionate Topical Solution USP, 0.05% w/w, 50 mL bottle, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufacturer: Macleods Pharmaceuticals Ltd Al Oxalis Labs Baddi Himachal Pradesh INDIA, UPC Code 33342032186 ---- NDC 33342-321-86

D-0492-2019
Recall number
D-0492-2019
Initiated
January 11, 2019
Classification
Class III
Status
Terminated
Recalling firm
Oxalis Labs
Quantity
53,358 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container; complaints of leakage.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container; complaints of leakage.

Code information

Lot Numbers: PCA801A, PCA802A, PCA803A, exp. date 12/2019; PCA804A, PCA805A, PCA806A, PCA807A, exp. date 04/2020

Distribution pattern

Product was distributed to 4 major distributors in IL, NY, AR, KY who may have further distribute the product throughout the United States.