PULMICORT RESPULES 0 — Class III drug recall D-199-2013
Terminated recall by AstraZeneca LP, reported 2013-03-20, distributed nationwide. Does Not Meet Monograph: Budesonide may be slightly above or below the specification range.
| Recall number | D-199-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AstraZeneca LP, Westborough, MA, United States |
| Recall initiated | 2013-01-11 |
| Classified | 2013-03-12 |
| Reported by FDA | 2013-03-20 |
| Terminated | 2013-07-26 |
| Distributed | Nationwide (US) |
| Quantity | 64,675 cartons |
| NDC | 00186-1988, 00186-1988-04, 00186-1989, 00186-1989-04, 00186-1990, 00186-1990-04 |
| Lot numbers | 11/13, 12/13, 2/14, 5/14, AB0077, AH0133, YP0035, YP0136, YP0140 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-199-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.