Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92639

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

Open FDA event record

Event summary

Timeline bucket
July 03, 2023
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Accord Healthcare, 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

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

Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-512-43.

D-0917-2023
Recall number
D-0917-2023
Initiated
July 03, 2023
Classification
Class II
Status
Terminated
Recalling firm
Accord Healthcare, Inc.
Quantity
2348 vials

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: Particulate matter identified as fiber.

Code information

Lot #: M2210154 Exp. date 06/2025; M2212575 Exp. date 08/2025

Distribution pattern

Nationwide within the United States

drug · product 2 of 2

Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67.

D-0918-2023
Recall number
D-0918-2023
Initiated
July 03, 2023
Classification
Class II
Status
Terminated
Recalling firm
Accord Healthcare, Inc.
Quantity
1680 vials

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: Particulate matter identified as fiber.

Code information

Lot #: M2212070 Exp. date 08/2024

Distribution pattern

Nationwide within the United States