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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65953

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

Open FDA event record

Event summary

Timeline bucket
August 09, 2013
Product types
Drug
Classifications
Class I and Class II
Statuses
Terminated
Recalling firm wording
Specialty Compounding, 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

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

CALCIUM GLUCONATE 2 gm (PF) PRESERVATIVE FREE in 100 mL Sodium Chloride 0.9% for Injection, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613

D-0230-2015
Recall number
D-0230-2015
Initiated
August 09, 2013
Classification
Class I
Status
Terminated
Quantity
Undetermined

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non Sterility: Microbial contamination

Code information

Lot #: 07092013M16; Exp 09/13

Distribution pattern

Nationwide

drug · product 2 of 2

All products, Rx Only Manufactured by Specialty Compounding, 211 S. Bell Blvd, Cedar Park, TX 78613

D-0231-2015
Recall number
D-0231-2015
Initiated
August 09, 2013
Classification
Class II
Status
Terminated
Quantity
Undetermined

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility

Code information

ALL lots of product on the market as of August 9, 2013.

Distribution pattern

Nationwide