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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84218

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

Open FDA event record

Event summary

Timeline bucket
November 06, 2019
Product types
Drug
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
AuroMedics Pharma 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

5 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 5

DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79

D-0526-2020
Recall number
D-0526-2020
Initiated
November 06, 2019
Classification
Class II
Status
Ongoing
Recalling firm
AuroMedics Pharma LLC
Quantity
69,696 bottles

App-derived interpretation

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: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Code information

Lot # NBSB19001DA3; Exp FEB 2021

Distribution pattern

nationwide

drug · product 2 of 5

Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60

D-0527-2020
Recall number
D-0527-2020
Initiated
November 06, 2019
Classification
Class II
Status
Ongoing
Recalling firm
AuroMedics Pharma LLC
Quantity
45,456 bottles

App-derived interpretation

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: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Code information

RA1518001-A Jul 2020 RA1518002-A Jul 2020 RA1518005-B Aug 2020 RA1518006-A Aug 2020 RA1519003-A May 2021

Distribution pattern

nationwide

drug · product 3 of 5

Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30

D-0528-2020
Recall number
D-0528-2020
Initiated
November 06, 2019
Classification
Class II
Status
Ongoing
Recalling firm
AuroMedics Pharma LLC
Quantity
134,160 bottles

App-derived interpretation

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: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Code information

RA3018001-A Jul 2020 RA3018002-A Jul-2020 RA3018003-A Jul 2020 RA3018004-A Aug 2020 RA3018005-A Aug 2020 RA3018006-A Aug 2020 RA3018007-A Sep 2020 RA3018008-A Sep 2020 RA3018009-A Sep 2020 RA3018010-A Oct 2020 RA3019001-A Jan 2021 RA3019002-A Jan 2021 RA3019003-A May 2021

Distribution pattern

nationwide

drug · product 4 of 5

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74

D-0529-2020
Recall number
D-0529-2020
Initiated
November 06, 2019
Classification
Class II
Status
Ongoing
Recalling firm
AuroMedics Pharma LLC
Quantity
19320 bottles

App-derived interpretation

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: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Code information

UI1519001-A UI1519002-A UI1519003-A UI1519004-A

Distribution pattern

nationwide

drug · product 5 of 5

Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-05

D-0530-2020
Recall number
D-0530-2020
Initiated
November 06, 2019
Classification
Class II
Status
Ongoing
Recalling firm
AuroMedics Pharma LLC
Quantity
26,736 bottles

App-derived interpretation

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: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Code information

RA1518002-B Jul 2020 RA1518003-A Jul 2020 RA1518004-A Aug 2020 RA1518005-A Aug 2020 RA1518007-A Sep 2020 RA1518008-A Sep 2020 RA1518009-A Sep 2020 RA1518010-A Oct 2020 RA1518011-A Nov 2020 RA1518012-A Nov 2020 RA1518013-A Nov 2020 RA1518014-A Nov 2020 RA1518015-A Nov 2020 RA1519003-B May 2021 RA1519004-A May 2021

Distribution pattern

nationwide