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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75640

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

Open FDA event record

Event summary

Timeline bucket
January 18, 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

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

Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 unit dose cups per case (NDC 66689-047-50), Rx only, Xact Dose, Manufactured by VistaPharm, Largo, FL 33771.

D-0469-2017
Recall number
D-0469-2017
Initiated
January 18, 2017
Classification
Class II
Status
Terminated
Recalling firm
VistaPharm, Inc.
Quantity
13,609 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container: Leakage of unit dose cups that may occur at the seal.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: Leakage of unit dose cups that may occur at the seal.

Code information

Lot #'s: 437600, Exp 07/17; 447100, Exp 10/17

Distribution pattern

Domestic: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA WI, & WV.