Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77247

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

Open FDA event record

Event summary

Timeline bucket
May 15, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Baxter Healthcare Corporation

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

Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1446, NDC 0338-6046-48

D-0788-2017
Recall number
D-0788-2017
Initiated
May 15, 2017
Classification
Class II
Status
Terminated
Quantity
113,590 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of assurance of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of assurance of sterility: customer complaints received for the presence of leaks.

Code information

Lot #: P344028/P344028A, Exp 12/31/17; P352377, Exp 8/31/18; P348136, Exp 4/30/18

Distribution pattern

US and foreign countries: United Arab Emirates, Colombia, and Canada

drug · product 2 of 2

Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose Intravia Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, NDC 0338-6010-48

D-0789-2017
Recall number
D-0789-2017
Initiated
May 15, 2017
Classification
Class II
Status
Terminated
Quantity
90,450 bags

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of assurance of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of assurance of sterility: customer complaints received for the presence of leaks.

Code information

Lot #: P342485, Exp 11/30/17; P344408, Exp 12/31/17

Distribution pattern

US and foreign countries: United Arab Emirates, Colombia, and Canada