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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92058

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

Open FDA event record

Event summary

Timeline bucket
March 17, 2023
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Amerisource Health Services LLC

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

Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories

D-0757-2023
Recall number
D-0757-2023
Initiated
March 17, 2023
Classification
Class II
Status
Terminated
Quantity
63,335 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: recalling drug products following an FDA inspection.

Code information

Batches a) P2002616, EXP 04/30/2023; P2006509, EXP 11/30/2023; P2103572, EXP 04/30/2024; P2106811, EXP 09/30/2024; R2200578, EXP 04/30/2025 b)P2100095, EXP 11/30/2023; P2100624, EXP 01/31/2024; P2101780, EXP 02/29/2024; P2107383, EXP 09/30/2024; P2201505, EXP 02/28/2025; R2201109, EXP 06/30/2025

Distribution pattern

Nationwide USA

drug · product 2 of 3

Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories

D-0758-2023
Recall number
D-0758-2023
Initiated
March 17, 2023
Classification
Class II
Status
Terminated
Quantity
105,361 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: recalling drug products following an FDA inspection.

Code information

Batches a)P2003493, EXP 05/31/2023; P2100120, EXP 11/30/2023; P2100683, EXP 01/31/2024; P2106002, EXP 07/31/2024; R2200148, EXP 12/31/2024; R2201125, EXP 06/30/2025 b) P2003403, EXP 05/31/2023; b) P2005800, EXP 09/30/2023; P2101156, EXP 01/31/2024; P2105401, EXP 07/31/2024; R2200083, EXP 12/31/2024; R2201004, EXP 07/31/2025

Distribution pattern

Nationwide USA

drug · product 3 of 3

Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories

D-0759-2023
Recall number
D-0759-2023
Initiated
March 17, 2023
Classification
Class II
Status
Terminated
Quantity
129,849 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: recalling drug products following an FDA inspection.

Code information

Batches a) P2003403, EXP 05/31/2023; P2006593, EXP 11/30/2023; P2101152, EXP 01/31/2024; P2105014, EXP 06/30/2024; R2101440, EXP 09/30/2024; P2200774, EXP 01/31/2025; R2200664, EXP 04/30/2025 b) P2100705, EXP 01/31/2024; P2104672, EXP 06/30/2024; R2101435, EXP 09/30/2024; R2200102, EXP 12/31/2024; R2200577, EXP 04/30/2025; P2205870, EXP 08/31/2025 [500 count] Lot, expiry: P2100121, exp 11/30/2023; P2100705, exp 01/31/2024; P2104672, exp 06/30/2024; R2101435, exp 09/30/2024; R2200102, exp 12/31/2024; R2200577, exp R2200577;P2205870, exp 08/31/2025

Distribution pattern

Nationwide USA