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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83871

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

Open FDA event record

Event summary

Timeline bucket
September 24, 2019
Product types
Drug
Classifications
Class II
Statuses
Completed
Recalling firm wording
Apotex 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

6 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 6

Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 a) 200 Tablets NDC 0363-1030-07; b) 24 Tablets NDC 0363-1030-02; c) 95 Tablets NDC 0363-1030-09; d) 65 Tablets NDC 0363-1030-06

D-0314-2020
Recall number
D-0314-2020
Initiated
September 24, 2019
Classification
Class II
Status
Completed
Recalling firm
Apotex Inc.
Quantity
259,647 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
impurity N-nitrosodimethylamine (NDMA

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).

Code information

All lots remaining within expiry.

Distribution pattern

Nationwide

drug · product 2 of 6

Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30 Tablets NDC 0363-1029-03 Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015

D-0315-2020
Recall number
D-0315-2020
Initiated
September 24, 2019
Classification
Class II
Status
Completed
Recalling firm
Apotex Inc.
Quantity
42,873 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
impurity N-nitrosodimethylamine (NDMA

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).

Code information

All lots remaining within expiry.

Distribution pattern

Nationwide

drug · product 3 of 6

Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack NDC: 49035-100-07; b) Single Pack NDC: 49035-100-00

D-0316-2020
Recall number
D-0316-2020
Initiated
September 24, 2019
Classification
Class II
Status
Completed
Recalling firm
Apotex Inc.
Quantity
1,132,453 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
impurity N-nitrosodimethylamine (NDMA

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).

Code information

All lots remaining within expiry.

Distribution pattern

Nationwide

drug · product 4 of 6

Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer 24 Tablets Sugar Free NDC 11822-6107-4 Distributed By: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011

D-0317-2020
Recall number
D-0317-2020
Initiated
September 24, 2019
Classification
Class II
Status
Completed
Recalling firm
Apotex Inc.
Quantity
31,968 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
impurity N-nitrosodimethylamine (NDMA

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).

Code information

All lots remaining within expiry.

Distribution pattern

Nationwide

drug · product 5 of 6

Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06 Distributed By: Wal-Mart Stores, Inc. Bentonville, AR 72716

D-0318-2020
Recall number
D-0318-2020
Initiated
September 24, 2019
Classification
Class II
Status
Completed
Recalling firm
Apotex Inc.
Quantity
162,344 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
impurity N-nitrosodimethylamine (NDMA

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).

Code information

All lots remaining within expiry.

Distribution pattern

Nationwide

drug · product 6 of 6

Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8

D-0319-2020
Recall number
D-0319-2020
Initiated
September 24, 2019
Classification
Class II
Status
Completed
Recalling firm
Apotex Inc.
Quantity
215,387 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
impurity N-nitrosodimethylamine (NDMA

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).

Code information

All lots remaining within expiry.

Distribution pattern

Nationwide