Exact FDA event identifier

Event 78048

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

Event summary

Timeline bucket: September 01, 2017
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

Sterile Water for Injection, USP Single Dose 100 mL vials, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045 USA for Genentech, Inc., South San Francisco, CA 94080-4990. NDC 50242-901-24

D-1177-2017

Recall number: D-1177-2017
Initiated: September 01, 2017
Classification: Class II
Status: Terminated
Recalling firm: Pfizer Inc.
Quantity: 18,725 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Non-Sterility: cracked or chipped glass at the neck of Sterile Water for Injection vials.

Code information

Lot: 63-075-DK Exp. FEB 2019

Distribution pattern

Nationwide in the USA