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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90161

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

Open FDA event record

Event summary

Timeline bucket
May 05, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Direct Rx

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

Losartan Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90

D-0971-2022
Recall number
D-0971-2022
Initiated
May 05, 2022
Classification
Class II
Status
Terminated
Recalling firm
Direct Rx
Quantity
81 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
AZIDO Impurity
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- AZIDO Impurity levels observed to be above acceptable limits

Code information

a) 30-count bottles- Lot: 11MY2103 Exp. 11/30/22 Lot: 05JA2106 Exp. 6/30/22 b) 90-count bottles- Lot: 20MY2115 Exp. 11/30/22 Lot: 22JU2118 Exp. 12/31/22 Lot: 29JY2113 Exp. 12/31/22 Lot: 13SE2113 Exp. 2/28/23 Lot: 05JA2106 Exp. 6/30/22

Distribution pattern

AL, GA, FL, LA

Field note

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