Class III · Lower riskRecall completed
Levalbuterol Inhalation Solution
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #: FA4022; Expiry: December 2015.
Where it was soldU.S. Nationwide including Puerto Rico.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byCipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640 foreign manufacturer
| Distributed by / for | Dr. Reddy's Laboratories, Inc., Princeton NJ 08640 |
| NDC | 43598-412-25 |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | Cipla Limited |
| Distribution | U.S. Nationwide including Puerto Rico. |
| Quantity | 140,625 Vials |
| Recall initiated | 2015-04-24 |
| Report date | 2015-05-20 |
| Recall completed | 2017-02-14 |
| Recall number | D-1078-2015 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Pithampur, District Dhar N/A India |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.