Exact FDA event identifier

Event 62053

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

Event summary

Timeline bucket: April 05, 2012
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Hospira, 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

Magnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g total, 50 mL Flexible Container, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-6729-24.

D-1390-2012

Recall number: D-1390-2012
Initiated: April 05, 2012
Classification: Class III
Status: Terminated
Recalling firm: Hospira, Inc.
Quantity: 164,568 containers

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.

Code information

Lot #: 04510KL*, Exp 01OCT2012; *lot number may have 01 or 02 following it

Distribution pattern

Nationwide