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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84696

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

Open FDA event record

Event summary

Timeline bucket
December 11, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
RemedyRepack 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

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

Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00

D-0798-2020
Recall number
D-0798-2020
Initiated
December 11, 2019
Classification
Class II
Status
Terminated
Recalling firm
RemedyRepack Inc.
Quantity
4,486 tablets

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviation

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.

Code information

Lot #: J0376034-052319, exp. date 05/2020 Lot #: J0406133-093019, exp. date 10/2020 Lot #: J038005-082719, exp. date 08/2020 Lot #: J0390280-072519, exp. date 07/2020 Lot #: J0390277-072519, exp. date 07/2020 Lot #: J0349352-012519, exp. date 01/2020

Distribution pattern

Product was distributed to two facilities in CA and NY.