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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69130

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

Open FDA event record

Event summary

Timeline bucket
September 08, 2014
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Baxter Healthcare Corp

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 Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container bags, Rx only, Baxter USA, product code 2B0826, NDC 0338-0709-48.

D-1606-2014
Recall number
D-1606-2014
Initiated
September 08, 2014
Classification
Class II
Status
Terminated
Recalling firm
Baxter Healthcare Corp
Quantity
148632 bags

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Correct Labeled Product Mispack: Shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.

Code information

Lot P318220, EXP 05/31/15

Distribution pattern

Nationwide