Drug 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.
D-1078-2015
Product summary
- Firm
- Cipla Limited
- Event
- Event 71133
- Status
- Terminated
- Classification
- Class III
- Quantity
- 140,625 Vials
- Official record key
drug-enforcement:D-1078-2015
Official wording
Reason: Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Code information: Lot #: FA4022; Expiry: December 2015.
Distribution pattern: U.S. Nationwide including Puerto Rico.
Derived failure modes
-
Potency or specification failure
out of specification