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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81943

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

Open FDA event record

Event summary

Timeline bucket
January 16, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Rx Pak Division of McKesson Corporation

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

Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards, For institutional use only, Mfg by: Aenova Holding GmBh, Miami, Fl 33186, NDC 63739-0478-10

D-1007-2019
Recall number
D-1007-2019
Initiated
January 16, 2019
Classification
Class II
Status
Terminated
Quantity
29,622 Blister Cards

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Label mix-up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate Sodium 100mg softgel caps.

Code information

Lot # 0119397, Exp 02/2020

Distribution pattern

Product was distributed to 5 major distributors who may have further distributed the product throughout the United States.