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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72099

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

Open FDA event record

Event summary

Timeline bucket
August 21, 2015
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

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 0487-0201-03) and b) 60 count (NDC 0487-0201-60) vials per carton, Rx only, Nephron Pharmaceutical Corporation, Orlando, FL

D-0010-2016
Recall number
D-0010-2016
Initiated
August 21, 2015
Classification
Class II
Status
Terminated
Quantity
a) 85,248 cartons and b) 35,292 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; potential exposure to non-sterile lubricant during the filling process

Code information

a) Lot D4E20A, exp 3/2016 and b) Lot D4C21A, exp 3/2016

Distribution pattern

Nationwide