Levalbuterol Inhalation Solution recall: Impurity Out of Spec
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…
Why was Levalbuterol Inhalation Solution recalled?
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: FA4022; Expiry: December 2015.
- 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…
- Recalling firm
- Cipla Limited
- Quantity
- 140,625 Vials
- Distribution
- U.S. Nationwide including Puerto Rico.
- Recall date
- May 20, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)