FDA DrugsClass II
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules...
Published: June 17, 2026Recall ID: D-0607-2026Category: drugsCountry: US
Reason for Recall / Hazard
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
Product Description & Identification
Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampules (5 Single-Dose Ampules per pouch, 6 pouches per carton, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Baska Ujeti Road, Ujeti Halol-289350, Gujarat, India, NDC 47335-633-49.
Additional Source Details
| Field | Value |
|---|---|
| City | Princeton |
| State | NJ |
| Openfda › Nui › 1 | N0000175576 |
| Openfda › Nui › 2 | N0000175450 |
| Openfda › Unii | Q3OKS62Q6X |
| Openfda › Route | RESPIRATORY (INHALATION) |
| Openfda › Rxcui › 1 | 252559 |
| Openfda › Rxcui › 2 | 349094 |
| Openfda › Rxcui › 3 | 351109 |
| Openfda › Spl id | c5265800-f7ea-4258-8555-5465104858a0 |
| Openfda › Brand name | BUDESONIDE |
| Openfda › Spl set id | a39fbcfc-3ffd-44bd-b882-01f8e1844213 |
| Openfda › Package ndc › 1 | 47335-631-48 |
| Openfda › Package ndc › 2 | 47335-631-49 |
| Openfda › Package ndc › 3 | 47335-632-48 |
| Openfda › Package ndc › 4 | 47335-632-49 |
| Openfda › Package ndc › 5 | 47335-633-48 |
| Openfda › Package ndc › 6 | 47335-633-49 |
| Openfda › Product ndc › 1 | 47335-631 |
| Openfda › Product ndc › 2 | 47335-632 |
| Openfda › Product ndc › 3 | 47335-633 |
| Openfda › Generic name | BUDESONIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | BUDESONIDE |
| Openfda › Pharm class epc | Corticosteroid [EPC] |
| Openfda › Pharm class moa | Corticosteroid Hormone Receptor Agonists [MoA] |
| Openfda › Manufacturer name | Sun Pharmaceutical Industries, Inc. |
| Openfda › Application number | ANDA211922 |
| Openfda › Is original packager | true |
| Event id | 99113 |
| Address 1 | 2 Independence Way |
| Address 2 | N/A |
| Code info | Lot #: BAG0074A, Exp. Date: 1/31/2027. |
| Postal code | 08540-6620 |
| Report date | 20260617 |
| Product type | Drugs |
| Product quantity | N/A |
| Reason for recall | 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 |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260529 |
| Initial firm notification | Letter |
| Center classification date | 20260618 |
Overview
- Recalling FirmSUN PHARMACEUTICAL INDUSTRIES INC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States