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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77638

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 26, 2017
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

2 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 2

Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50

D-1052-2017
Recall number
D-1052-2017
Initiated
June 26, 2017
Classification
Class II
Status
Terminated
Recalling firm
VistaPharm, Inc.
Quantity
6150 cases

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.

Code information

Lot #: 468300, Exp 09/2018; 474400, Exp 11/2018

Distribution pattern

CA, IL, LA, NH, OH, PA, SC

drug · product 2 of 2

Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01

D-1053-2017
Recall number
D-1053-2017
Initiated
June 26, 2017
Classification
Class II
Status
Terminated
Recalling firm
VistaPharm, Inc.
Quantity
9945 cases

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.

Code information

Lot #: 458300, Exp 09/2018; 462600, Exp 07/2018; 471000, Exp 10/2018; 474300, Exp 11/2018

Distribution pattern

CA, IL, LA, NH, OH, PA, SC