Recalls / Class III
Class IIID-1078-2015
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.-454 775, INDIA, Manufactured for: Dr. Reddy's Laboratories, Inc., Princeton NJ 08640. NDC: 43598-412-25.
- Affected lot / code info
- Lot #: FA4022; Expiry: December 2015.
Why it was recalled
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Recalling firm
- Firm
- Cipla Limited
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- Plot No. 9 & 10 Pharma Zone Phase II, Section III Indore Special Economic Zone, Pithampur, District Dhar, N/A N/A, India
Distribution
- Quantity
- 140,625 Vials
- Distribution pattern
- U.S. Nationwide including Puerto Rico.
Timeline
- Recall initiated
- 2015-04-24
- FDA classified
- 2015-05-14
- Posted by FDA
- 2015-05-20
- Terminated
- 2017-02-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1078-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.