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

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

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
Recalling firm: Nephron Pharmaceuticals Corp.
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