Class II ยท Moderate risk
Budesonide Inhalation Suspension
Presence of Foreign Substance:This recall has been initiated in response to a product quality complaint reported for black/brown specs and particles within the ampoule solution
National Drug Code
Is NDC 47335-0633-49 recalled?
Budesonide · 6 POUCH in 1 CARTON (47335-633-49) / 5 AMPULE in 1 POUCH (47335-633-48) / 2 mL in 1 AMPULE
Yes — this exact package was recalled
1 FDA recall names the code 47335-0633-49 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
1 of these recalls is still ongoing.
- Active ingredient
- Budesonide
- Strength
- BUDESONIDE 1 mg/2mL
- Form
- Suspension · Respiratory (inhalation)
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Type
- Human Prescription Drug
- Product code
- 47335-0633
Recalls naming this package
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 47335-0737 Bupropion hydrochloride 6
- 47335-0738 Bupropion hydrochloride 5
- 47335-0506 Cequa 4
- 47335-0063 Dofetilide 2
- 47335-0343 See recall 2
- 47335-0049 Doxorubicin Hydrochloride 1
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.