Exact FDA event identifier

Event 78175

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

Event summary

Timeline bucket: September 25, 2017
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: RXQ 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

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

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

methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10

D-0012-2018

Recall number: D-0012-2018
Initiated: September 25, 2017
Classification: Class II
Status: Terminated
Recalling firm: RXQ Compounding LLC
Quantity: 945 vials

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; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.

Code information

Lot: 04252017@1, exp 5/9/2018

Distribution pattern

TX, LA, PA, MA, FL, and OH