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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89447

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

Open FDA event record

Event summary

Timeline bucket
January 19, 2022
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Dr. Reddy's Laboratories, 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

3 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 3

Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-305-62

D-0575-2022
Recall number
D-0575-2022
Initiated
January 19, 2022
Classification
Class III
Status
Terminated
Quantity
68061 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed stability specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed stability specifications

Code information

Lot #: H200101, H200102, H200099, H200100 & H200106, Exp 8/1/2023; H210015, H210014 & H210013, Exp 11/1/2023; H210086, Exp 12/1/2023; H210130, Exp 1/1/2024; H210171, H210172, H210173, H210174, Exp 2/1/2024; H210196 & H210197, Exp 3/1/2024; H210283 & H210282, Exp 4/1/2024; H210382, H210381, H210419 & H210420, Exp 7/1/2024, H210445, Exp 8/1/2024.

Distribution pattern

USA Nationwide

drug · product 2 of 3

Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-465-62

D-0576-2022
Recall number
D-0576-2022
Initiated
January 19, 2022
Classification
Class III
Status
Terminated
Quantity
18261 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed stability specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed stability specifications

Code information

Lot#: H200107, Exp 8/1/2023; H200154, Exp 9/1/2023; H210020, Exp 11/1/2023; H210055, Exp 12/1/2023; H210129, Exp 1/1/2024, H210288, Exp 4/1/2024.

Distribution pattern

USA Nationwide

drug · product 3 of 3

Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-865-60

D-0577-2022
Recall number
D-0577-2022
Initiated
January 19, 2022
Classification
Class III
Status
Terminated
Quantity
2,980 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed stability specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed stability specifications

Code information

Lot # H210233, Exp 3/1/2023

Distribution pattern

USA Nationwide