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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83434

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

Open FDA event record

Event summary

Timeline bucket
July 24, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Alvogen, 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

2 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 2

Nitrofurantoin Monohydrate/Macrycrystals Capsules, 100 mg, 100-count bottle, Rx Only, Distributed by: Alvogen, Inc. Pine Brook, NY 07058 USA, NDC 47781-303-01

D-1722-2019
Recall number
D-1722-2019
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Alvogen, Inc
Quantity
2784 bottles

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed dissolution specifications

Code information

Lot # 471976, Exp 03/2020

Distribution pattern

Natonwide, PR

drug · product 2 of 2

Macrobid Urinary Tract Anitbacterial, 100 mg, 100-count bottle, Rx Only, Mfg. by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 USA Dist. by: Almatica Pharma, Inc. Pine Brook, NJ 07058 USA, NDC 52427-285-01

D-1723-2019
Recall number
D-1723-2019
Initiated
July 24, 2019
Classification
Class II
Status
Terminated
Recalling firm
Alvogen, Inc
Quantity
4272 bottles

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed dissolution specifications

Code information

Lot # 472990, Exp 03/2020

Distribution pattern

Natonwide, PR