Exact FDA event identifier

Event 89556

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

Event summary

Timeline bucket: February 15, 2022
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: ANI Pharmaceuticals, 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

5 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 5

Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-900-50), and c) 1000-count bottles (NDC 67253-900-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977

D-0564-2022

Recall number: D-0564-2022
Initiated: February 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: ANI Pharmaceuticals, Inc.
Quantity: 73,920 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations

Code information

Lot #: a) 19C003A, Exp. Date 03/2022; 19G002A, exp. date 07/2022; b) 19C004B, Exp. Date 03/2022; c) 19C048C, Exp. Date 03/2022

Distribution pattern

Nationwide within the United States

drug · product 2 of 5

Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bottles (NDC 67253-901-50), and c) 1000-count bottles (NDC 67253-901-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977

D-0565-2022

Recall number: D-0565-2022
Initiated: February 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: ANI Pharmaceuticals, Inc.
Quantity: 205,662 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations

Code information

Lot #: a) 19B029A, Exp. Date 02/2022; 19D021A, Exp. Date 04/2022. b) 19A087B, 19A088B, 19A089B, 19A090B, Exp. Date 02/2022; 19A086B, 19A091B, 19B019B, Exp. Date 02/2022. c) 19B020C, 19B021C, 19B027C, 19B028C, Exp. Date 02/2022, 19E056C, 19E057C, Exp. Date 05/2022; 19E059C, Exp. Date 06/2022 19G072C, Exp. Date 07/2022

Distribution pattern

Nationwide within the United States

drug · product 3 of 5

Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count bottles (NDC 67253-902-50), and c) 1000-count bottles (NDC 67253-902-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977

D-0566-2022

Recall number: D-0566-2022
Initiated: February 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: ANI Pharmaceuticals, Inc.
Quantity: 173,499 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations

Code information

Lot #: a) 19B081A, Exp. Date 02/2022; 19E088A, 19E089A, Exp. Date 05/2022 b) 19A102B, Exp. Date 02/2022; 19D067B, 19D068B, Exp. Date 04/2022; 19D070C, Exp. Date 05/2022. c) 19F045C, 19F046C, Exp. Date 06/2022; 19B082C, 19B083C, Exp. Date 03/2022; 19D069C, Exp. Date 05/2022.

Distribution pattern

Nationwide within the United States

drug · product 4 of 5

Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bottles (NDC 67253-903-50), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977

D-0567-2022

Recall number: D-0567-2022
Initiated: February 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: ANI Pharmaceuticals, Inc.
Quantity: 70,788 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations

Code information

Lot #: a) 19C002A, Exp. Date 03/2022; 19E012A, 19E013A, Exp. Date 05/2022. b) 19C100B, Exp. Date 04/2022; 19E001B, 19E002B, Exp. Date 05/2022.

Distribution pattern

Nationwide within the United States

drug · product 5 of 5

Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY 12528, Distributed by Par Pharmaceuticals, Chestnut Ridge, NY 10977, NDC 67253-660-10.

D-0568-2022

Recall number: D-0568-2022
Initiated: February 15, 2022
Classification: Class II
Status: Terminated
Recalling firm: ANI Pharmaceuticals, Inc.
Quantity: 5,477 bottles

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations

Code information

Lot #: 19B064A, Exp. Date 03/2022

Distribution pattern

Nationwide within the United States