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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84208

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

Open FDA event record

Event summary

Timeline bucket
November 01, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
American Health Packaging

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 Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)

D-0631-2020
Recall number
D-0631-2020
Initiated
November 01, 2019
Classification
Class II
Status
Terminated
Recalling firm
American Health Packaging
Quantity
1,692 cases of 40 and 50 cups

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
NDMA impurity
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: Presence of NDMA impurity detected in product.

Code information

[Case of 40] Lots 183723, 184278, exp 10/31/2020; Lot 187652, exp 05/31/2021; [Case of 50] Lot 177874, exp 01/31/ 2020; Lot 178413, exp 02/29/ 2020; Lot 183449, exp 10/31/2020; Lot 184445, exp 12/31/ 2020; Lot 186563, exp 03/31/ 2021; Lot 187691, exp 05/31/2021

Distribution pattern

Nationwide USA