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

FDA recall notice · announced March 20, 2013 · Astrazeneca

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: Nationwide
Lot/code information: Lot/Exp Date: YP0035 11/13; YP0140 12/13; YP0136 12/13; AB0077 2/14; AH0133 5/14
Quantity: 64675 cartons
Status: Terminated
Products in this recall event:
- PULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04 (D-198-2013)
- PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04 (D-199-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.