Exact FDA event identifier

Event 85507

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

Event summary

Timeline bucket: April 18, 2020
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: B. Braun Medical 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

Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11

D-1257-2020

Recall number: D-1257-2020
Initiated: April 18, 2020
Classification: Class I
Status: Terminated
Recalling firm: B. Braun Medical Inc
Quantity: 22,488 Duplex containers

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 Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.

Code information

Lot #: H8J812, Exp. Date 31 JUL 2020

Distribution pattern

Product was distributed nationwide within the United States.