Exact FDA event identifier

Event 77998

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

Event summary

Timeline bucket: August 17, 2017
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: VistaPharm, 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

Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16

D-1139-2017

Recall number: D-1139-2017
Initiated: August 17, 2017
Classification: Class III
Status: Terminated
Recalling firm: VistaPharm, Inc.
Quantity: 3084 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

incorrectly labeled

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance

Code information

Lot: 494700 Exp. 10/2018

Distribution pattern

Nationwide