Reported May 20, 2015 · Terminated
Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only. Manufactured by: Cipla Ltd. Plot 9 & 10,…
Cipla Limited
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cipla Limited · Plot No. 9 & 10 Pharma Zone Phase II · Pithampur, District Dhar, N/A · N/A
Is this the product you have?
- Levalbuterol Inhalation Solution, USP, 0.31 mg/ 3 mL, 3 mL Vials, Rx Only
- Manufactured byCipla Ltd. Plot 9 & 10, Indure, SEZ, Pithampur, M.P.-454 775, INDIA
- Manufactured forDr. Reddy's Laboratories, Inc., Princeton NJ 08640
- NDC43598-412-25
- Lot codes and dates
- Lot #: FA4022
- ExpiryDecember 2015
- Amount recalled
- 140,625 Vials
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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