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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80399

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

Open FDA event record

Event summary

Timeline bucket
June 28, 2018
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
PFIZER

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

Daptomycin for Injection, 500 mg per vial, packaged as 1 Single-dose vial per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-0106-01.

D-1023-2018
Recall number
D-1023-2018
Initiated
June 28, 2018
Classification
Class II
Status
Terminated
Recalling firm
PFIZER
Quantity
234,680 vials

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
Microbial Contamination

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Microbial Contamination of Sterile Products: Product associated with reports of adverse events indicative of infusion reactions related to microbiological contamination.

Code information

Lot #: 712453A, Exp 1-Nov-18; 771803A, Exp 1-May-19; 792103A, Exp 1-Jul-19; 800903A, Exp 1-Aug-19; 810853A, Exp 1-Sep-19; 841703A, 841753A, Exp 1-Dec-19; 850553A, Exp 1-Jan-20.

Distribution pattern

Nationwide in the USA and Puerto Rico.