Home / Recalls / Cipla Limited / D-1078-2015

D-1078-2015 Class III Terminated

Recalled by Cipla Limited — Pithampur, District Dhar, N/A

FDA drug recall D-1078-2015 was initiated by Cipla Limited on Apr 24, 2015 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant. The recall status is terminated (terminated Feb 14, 2017). Affected quantity: 140,625 Vials.

Recall Details

Product Type: Drugs
Report Date: May 20, 2015
Initiation Date: Apr 24, 2015
Termination Date: Feb 14, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 140,625 Vials

Product Description

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.

Reason for Recall

Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.

Distribution Pattern

U.S. Nationwide including Puerto Rico.

Code Information

Lot #: FA4022; Expiry: December 2015.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1078-2015
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.