Cipla USA

Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.

Jul 24, 2025 Other Drugs Nationwide View Details →

Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton, five per pouch, RX Only, Manufactured by: Cipla Ltd. Indore SEZ, Pithampur, India. Manufactured for: Ciple USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC# 69097-319-86 (pouch), 69097-319-87 (carton)

Class I - Dangerous

Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.

Jun 30, 2025 Prescription Drugs Nationwide View Details →

Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98

Class I - Dangerous

Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.

Oct 23, 2024 Prescription Drugs Nationwide View Details →

Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90

Class I - Dangerous

Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.

Oct 23, 2024 Prescription Drugs Nationwide View Details →

Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton containing 30 vials ( 6 pouches of 5 - 3 mL vials), Rx only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-173-53

Class I - Dangerous

Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.

Mar 26, 2024 Prescription Drugs Nationwide View Details →

Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net content 6.7 g canister packaged in a box, Rx only, Manufactured by: Cipla Ltd, Indore SE Z, Pithampur, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ, 07059, NDC 69097-142-60

Class I - Dangerous

Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).

Jun 27, 2023 Prescription Drugs Nationwide View Details →