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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91977

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

Open FDA event record

Event summary

Timeline bucket
March 29, 2023
Product types
Drug
Classifications
Class III
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

Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use Only, Rx Only, Sterile, Manufactured by: Intas Pharmaceuticals Limited Pharmaz Ahnedabad 382 213, INDIA, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, NDC 16729-533-08.

D-0528-2023
Recall number
D-0528-2023
Initiated
March 29, 2023
Classification
Class III
Status
Terminated
Recalling firm
Accord Healthcare, Inc.
Quantity
4574 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Sub-potent drug: assay test result below specifications at 9-month timepoint.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Sub-potent drug: assay test result below specifications at 9-month timepoint.

Code information

Lot #: R2200394 Exp. 03/2024

Distribution pattern

Nationwide in the USA.