Exact FDA event identifier

Event 79238

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

Open FDA event record

Event summary

Timeline bucket: February 20, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Hospira Inc. A Pfizer Company

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

Labetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-20; and b) NOVAPLUS, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-25.

D-0576-2018

Recall number: D-0576-2018
Initiated: February 20, 2018
Classification: Class II
Status: Terminated
Recalling firm: Hospira Inc. A Pfizer Company
Quantity: a) 137,975 vials; b) 40,143 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.

Code information

Lots: a) 74370DD, Exp 1FEB2019; 75035DD, 75115DD, Exp 1MAR2019; b) 74230DD, Exp 1FEB2019

Distribution pattern

Nationwide in the USA and Puerto Rico.