Exact FDA event identifier

Event 85054

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

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Event summary

Timeline bucket: February 24, 2020
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Breckenridge Pharmaceutical, 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

Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Carton, Rx Only, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, Manufactured by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 51991-064-98.

D-1063-2020

Recall number: D-1063-2020
Initiated: February 24, 2020
Classification: Class III
Status: Terminated
Recalling firm: Breckenridge Pharmaceutical, Inc
Quantity: 900 Vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing.

Code information

Lot # 5553.044E; 5553.044F, Exp. 04/30/2021

Distribution pattern

Nationwide in the U.S.