Exact FDA event identifier

Event 82969

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

Event summary

Timeline bucket: May 28, 2019
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Synthetopes 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

8 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 8

Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.

D-1399-2019

Recall number: D-1399-2019
Initiated: May 28, 2019
Classification: Class II
Status: Terminated
Recalling firm: Synthetopes Inc
Quantity: 20 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

All lots remaining within expiry.

Distribution pattern

Nationwide.

drug · product 2 of 8

Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc.

D-1400-2019

Recall number: D-1400-2019
Initiated: May 28, 2019
Classification: Class II
Status: Terminated
Recalling firm: Synthetopes Inc
Quantity: 3 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

All lots remaining within expiry.

Distribution pattern

Nationwide.

drug · product 3 of 8

Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.

D-1401-2019

Recall number: D-1401-2019
Initiated: May 28, 2019
Classification: Class II
Status: Terminated
Recalling firm: Synthetopes Inc
Quantity: 35 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

All lots remaining within expiry.

Distribution pattern

Nationwide.

drug · product 4 of 8

Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.

D-1402-2019

Recall number: D-1402-2019
Initiated: May 28, 2019
Classification: Class II
Status: Terminated
Recalling firm: Synthetopes Inc
Quantity: 20 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

All lots remaining within expiry.

Distribution pattern

Nationwide.

drug · product 5 of 8

Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, Synthetopes, Inc.

D-1403-2019

Recall number: D-1403-2019
Initiated: May 28, 2019
Classification: Class II
Status: Terminated
Recalling firm: Synthetopes Inc
Quantity: 68 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

All lots remaining within expiry.

Distribution pattern

Nationwide.

drug · product 6 of 8

Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.

D-1404-2019

Recall number: D-1404-2019
Initiated: May 28, 2019
Classification: Class II
Status: Terminated
Recalling firm: Synthetopes Inc
Quantity: 82 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

All lots remaining within expiry.

Distribution pattern

Nationwide.

drug · product 7 of 8

Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.

D-1405-2019

Recall number: D-1405-2019
Initiated: May 28, 2019
Classification: Class II
Status: Terminated
Recalling firm: Synthetopes Inc
Quantity: Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

All lots remaining within expiry.

Distribution pattern

Nationwide.

drug · product 8 of 8

Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.

D-1406-2019

Recall number: D-1406-2019
Initiated: May 28, 2019
Classification: Class II
Status: Terminated
Recalling firm: Synthetopes Inc
Quantity: 45 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0

Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Processing Controls.

Code information

All lots remaining within expiry.

Distribution pattern

Nationwide.