Exact FDA event identifier

Event 80005

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

Event summary

Timeline bucket: April 26, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Coast Quality Pharmacy 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

Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol 200 mL/0.125 mL lyophilized powder in 10 mL glass vial, Rx only, AnazaoHealth, Tampa, FL

D-0801-2018

Recall number: D-0801-2018
Initiated: April 26, 2018
Classification: Class II
Status: Terminated
Recalling firm: Coast Quality Pharmacy LLC
Quantity: 52 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

Code information

Lot: MAA-171219BM BUD: 4/19/18; MAA-180226BM BUD: 06/26/18

Distribution pattern

AL, CA, FL, MI, SC, TX