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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82947

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

Open FDA event record

Event summary

Timeline bucket
May 06, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Geritrex, 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

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

Senna (sennosides 8.8 mg) Syrup, 8 fl oz. (237 mL) bottles, Rij Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NY 10941, NDC 53807-556-08

D-1436-2019
Recall number
D-1436-2019
Initiated
May 06, 2019
Classification
Class II
Status
Terminated
Recalling firm
Geritrex, LLC
Quantity
1536 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported

Code information

Lot #: 1804012, Exp. 08/2019

Distribution pattern

Nationwide within the United States

drug · product 2 of 2

Senna (sennosides 8.8 mg) Syrup 8 fl oz. (236 mL) bottles, Distributed by Geritrex, LLC 40 Commercial Avenue Middletown, NY 10941, NDC 54162-007-08

D-1437-2019
Recall number
D-1437-2019
Initiated
May 06, 2019
Classification
Class II
Status
Terminated
Recalling firm
Geritrex, LLC
Quantity
24312 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: Atypical odor and unpleasant taste was reported

Code information

Lot #: 1806031, 1806014, Exp. 08/2019

Distribution pattern

Nationwide within the United States