FDA recall D-199-2013

Product

PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04

Reason for recall

Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-01-11

Report date

2013-03-20

Termination date

2013-07-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Westborough, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-199-2013