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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88547

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

Open FDA event record

Event summary

Timeline bucket
August 24, 2021
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Azurity Pharmaceuticals, 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

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

Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g Vancomycin Hydrochloride USP, powder for oral solution and 1 bottle containing 145 mL Grape Flavored Diluent for reconstitution per carton, Rx only, Manufactured for: Azurity pharmaceuticals, Wilmington, MA 01887, NDC 65628-206-05.

D-0003-2022
Recall number
D-0003-2022
Initiated
August 24, 2021
Classification
Class I
Status
Terminated
Quantity
2,751 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product Mix-up: Incorrect diluent component included in the kit.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Product Mix-up: Incorrect diluent component included in the kit.

Code information

Lot # 21035, Exp 7/31/2022

Distribution pattern

USA nationwide