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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84610

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

Open FDA event record

Event summary

Timeline bucket
January 07, 2020
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Appco 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

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 Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.

D-0648-2020
Recall number
D-0648-2020
Initiated
January 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Appco Pharma LLC
Quantity
1,632 bottes

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

Batch # 1905227UE, exp. date Apr-2021 1905228UE, exp. date Apr-2021

Distribution pattern

Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.

drug · product 2 of 2

Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623.

D-0649-2020
Recall number
D-0649-2020
Initiated
January 07, 2020
Classification
Class II
Status
Terminated
Recalling firm
Appco Pharma LLC
Quantity
624 bottes

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

Batch # 1905225VN, exp. date Apr-2021 1905226VD, exp. date Apr-2021 1906295UN, exp. date May-2021 1906296UN, exp. date May-2021 1906297UN, exp. date May-2021 1906298UD, exp. date May-2021

Distribution pattern

Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.