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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78974

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

Open FDA event record

Event summary

Timeline bucket
January 19, 2018
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
G & W Laboratories, 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

Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (NDC 0713-0638-18), Rx Only, Manufactured by: G&W Laboratories, Inc., South Plainfield, NJ 07080.

D-0250-2018
Recall number
D-0250-2018
Initiated
January 19, 2018
Classification
Class III
Status
Terminated
Recalling firm
G & W Laboratories, Inc.
Quantity
142,236 tubes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.

Code information

Lot #: a) 1002896, Exp 09/18; 1005797, Exp 05/19; 1006100, Exp 07/19; b) 1002561, Exp 06/18; 1002897, Exp 09/18; 1005798, Exp 05/19; 1006101, Exp 07/19; c) 1002898, Exp 10/18; 1004283, Exp 12/18; 1005837, Exp 05/19; 1006321, 1006322, Exp 07/19

Distribution pattern

Nationwide in the USA and Puerto Rico