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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86529

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

Open FDA event record

Event summary

Timeline bucket
October 07, 2020
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

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

Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 mg/2 mL) 10 x 2 mL single-dose ampules, Rx only, Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA, Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213 India, NDC 36000-092-10

D-0076-2021
Recall number
D-0076-2021
Initiated
October 07, 2020
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulate matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of particulate matter in solution - black and transparent particles

Code information

Lot #: A0B1241, Exp 10/2020; A0C0091, Exp 12/2020; A0D0268, Exp 02/2022

Distribution pattern

Nationwide USA