Exact FDA event identifier

Event 78928

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

Event summary

Timeline bucket: January 11, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Premier Pharmacy Labs 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

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

Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35.

D-0251-2018

Recall number: D-0251-2018
Initiated: January 11, 2018
Classification: Class II
Status: Terminated
Recalling firm: Premier Pharmacy Labs Inc
Quantity: 193 vials

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Label Error

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Error on Declared Strength

Code information

Lot: MIT100217SVDS BUD: 03/01/2018

Distribution pattern

Nationwide.