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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84583

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

Open FDA event record

Event summary

Timeline bucket
December 26, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
AAA Pharmaceutical, 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

Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.

D-0645-2020
Recall number
D-0645-2020
Initiated
December 26, 2019
Classification
Class II
Status
Terminated
Recalling firm
AAA Pharmaceutical, Inc.
Quantity
34,272 (24-count bottles)

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Impurity N-nitrosodimethylamine (NDMA
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: Impurity N-nitrosodimethylamine (NDMA) found in API

Code information

P134458, Sept 2020 P134943, Aug 2020 P135840, Aug, 2020 P136622, April 2021 P136871, April 2021 P137347, April 2021 P137424, April 2021

Distribution pattern

Product was distributed to one consignee who may have distributed the product further to their retail stores.

drug · product 2 of 2

Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.

D-0646-2020
Recall number
D-0646-2020
Initiated
December 26, 2019
Classification
Class II
Status
Terminated
Recalling firm
AAA Pharmaceutical, Inc.
Quantity
31,536 (130-count bottles)

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
Impurity N-nitrosodimethylamine (NDMA
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: Impurity N-nitrosodimethylamine (NDMA) found in API

Code information

P134457, Sept 2020 P135156, Aug 2020 P135156, Aug 2020 P135243, Aug 2020 P135877, Sept 2020 P136145, Aug 2020 P136146, Sept 2020 P136623, April 2021 P136728, April, 2021 P136994, April, 2021 P137348, April, 2021 P137423, April, 2021 P137499, April, 2021

Distribution pattern

Product was distributed to one consignee who may have distributed the product further to their retail stores.