Exact FDA event identifier

Event 81311

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

Event summary

Timeline bucket: September 20, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Pfizer 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

Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 60045, USA. NDC carton: 0409-3506-01; NDC vial: 0409-3506-11

D-0095-2019

Recall number: D-0095-2019
Initiated: September 20, 2018
Classification: Class II
Status: Terminated
Recalling firm: Pfizer Inc.
Quantity: 71,075 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: loss of container integrity.

Code information

Lot: 609G047, EXP 10/2018

Distribution pattern

Nationwide in the US and Puerto Rico