FDA Drug recall D-1078-2015
Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only
- FDA Drug
- Class III
- terminated
- Published 2015-05-20
On 2015-05-20 the FDA classified a Class III recall of Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only by Cipla, citing failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1078-2015 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-04-24 |
| Published | 2015-05-20 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Cipla |
| Distribution | US |
Product
Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25.
Reason
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Identifiers
| code_info | Lot #: FA4022; Expiry: December 2015. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1078-2015%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.