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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62405

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

Open FDA event record

Event summary

Timeline bucket
May 30, 2012
Product types
Drug
Classifications
Class II
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

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 & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-16.

D-1416-2012
Recall number
D-1416-2012
Initiated
May 30, 2012
Classification
Class II
Status
Terminated
Recalling firm
VistaPharm, Inc.
Quantity
a) 949 Cases, b) 188 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Impurities/Degradation Products: exceeded specification at 3 month stability testing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Impurities/Degradation Products: exceeded specification at 3 month stability testing

Code information

Lot #'s a) 251400, Exp 07/13; b) 251500 Exp 07/13.

Distribution pattern

Nationwide