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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91228

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

Open FDA event record

Event summary

Timeline bucket
November 29, 2022
Product types
Drug
Classifications
Class I
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

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

Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05

D-0131-2023
Recall number
D-0131-2023
Initiated
November 29, 2022
Classification
Class I
Status
Terminated
Recalling firm
Accord Healthcare, Inc.
Quantity
Unknown

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling mixup

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial

Code information

Lot: R2200232 Exp. 01/2025

Distribution pattern

Nationwide within the United States