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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96433

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

Open FDA event record

Event summary

Timeline bucket
March 07, 2025
Product types
Drug
Classifications
Class II
Statuses
Completed
Recalling firm wording
Slate Run Pharmaceuticals

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

Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04

D-0278-2025
Recall number
D-0278-2025
Initiated
March 07, 2025
Classification
Class II
Status
Completed
Recalling firm
Slate Run Pharmaceuticals
Quantity
56,790 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
nitrosamine 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: The presence of nitrosamine impurity above the acceptable daily intake limits.

Code information

Lot # 07711, Exp 07/2025; 08900, Exp 09/2026; 08899, Exp 09/2026

Distribution pattern

Product was distributed to 8 distributors who may have further distribute the product nationwide.

drug · product 2 of 2

Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04

D-0279-2025
Recall number
D-0279-2025
Initiated
March 07, 2025
Classification
Class II
Status
Completed
Recalling firm
Slate Run Pharmaceuticals
Quantity
2,444 bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
nitrosamine 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: The presence of nitrosamine impurity above the acceptable daily intake limits.

Code information

Lot # 109797, Exp 11/2026

Distribution pattern

Product was distributed to 8 distributors who may have further distribute the product nationwide.