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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85039

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

Open FDA event record

Event summary

Timeline bucket
November 13, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Precision Dose 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 Oral Solution, USP, 150 mg/10 mL, [10 mL x 30 Unit Dose Cups per case, NDC: 68094-204-62; 10 mL x 100 Unit Dose Cups per case, NDC: 68094-204-61; Unit Dose Cup NDC: 68094-204-59], Rx only, Precision Dose, Inc., South Beloit, IL 61080

D-1004-2020
Recall number
D-1004-2020
Initiated
November 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
Precision Dose Inc.
Quantity
224,940 unit dose cups

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

Lot number: 501290, Expiry: 11/30/19, NDC: 68094-204-61; Lot number: 501326, Expiry: 11/30/19, NDC: 68094-204-62; Lot number: 501501, Expiry: 11/30/19, NDC: 68094-204-62; Lot number: 1592, Expiry: 4/30/20, NDC: 68094-204-62; Lot number: 501679, Expiry: 4/30/20, NDC: 68094-204-61, 68094-204-62

Distribution pattern

Nationwide USA