Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62604

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

Open FDA event record

Event summary

Timeline bucket
June 22, 2011
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Nephron Pharmaceuticals Corp.

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

Albuterol Sulfate Inhalation Solution, 0.083%, 2.5 mg/3 mL Sterile Unit-Dose Vials, 60-count (60 x 3 mL Sterile Unit-Dose Vials) per carton, Rx only, Manufactured by: nephron pharmaceuticals corporation, Orlando, FL 32811, NDC 0487-9501-60.

D-1446-2012
Recall number
D-1446-2012
Initiated
June 22, 2011
Classification
Class II
Status
Terminated
Quantity
56,028 cartons

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

Code information

Lot #: A0654A, Exp 07/12; A0A62A, Exp 10/12

Distribution pattern

Nationwide and Puerto Rico