FDA Drug recall D-199-2013
PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04
- FDA Drug
- Class III
- terminated
- Published 2013-03-20
On 2013-03-20 the FDA classified a Class III recall of PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04 by Astrazeneca, citing does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-199-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-01-11 |
| Published | 2013-03-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Astrazeneca |
| Distribution | US |
Product
PULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04
Reason
Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Identifiers
| ndc | 0186-1988-04 |
|---|---|
| ndc | 0186-1989-04 |
| ndc | 0186-1990-04 |
| code_info | Lot/Exp Date: YP0035 11/13; YP0140 12/13; YP0136 12/13; AB0077 2/14; AH0133 5/14 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-199-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.