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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78669

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

Open FDA event record

Event summary

Timeline bucket
November 30, 2017
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Intrathecal Compounding Specialist, 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

4 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 4

All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017 Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.

D-0320-2018
Recall number
D-0320-2018
Initiated
November 30, 2017
Classification
Class II
Status
Terminated
Quantity
Unknown.

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

All lots remaining within expiry (BUDs between November 15, 2017 and December 16, 2017)

Distribution pattern

Nationwide

drug · product 2 of 4

All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.

D-0321-2018
Recall number
D-0321-2018
Initiated
November 30, 2017
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

All lots remaining within expiry (BUDs between November 15, 2017 and December 16, 2017).

Distribution pattern

Nationwide

drug · product 3 of 4

All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.

D-0322-2018
Recall number
D-0322-2018
Initiated
November 30, 2017
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

All lots remaining within expiry (BUD between November 15, 2017 and December 16, 2017).

Distribution pattern

Nationwide

drug · product 4 of 4

All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.

D-0323-2018
Recall number
D-0323-2018
Initiated
November 30, 2017
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
Lack of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of sterility assurance.

Code information

All lots remaining within expiry (BUDs between November 15, 2017 and December 16, 2017).

Distribution pattern

Nationwide