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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85538

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

Open FDA event record

Event summary

Timeline bucket
April 21, 2020
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Sandoz, 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

Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2, Rx Only, Distributed by: Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA, NDC 54643-5647-0

D-1259-2020
Recall number
D-1259-2020
Initiated
April 21, 2020
Classification
Class II
Status
Terminated
Recalling firm
Sandoz, Inc
Quantity
17,500 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins

Code information

Lot #: JX907, Exp. Date 02/2021

Distribution pattern

Nationwide within the United States