fda
16 records
FDA Recall: Cipla USA, Inc. — Class II
20260422
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit | Product: Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd.
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FDA Drug Recall: Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactur
2026-03-11
Class III — Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
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FDA Drug Recall: Nilotinib Capsules, 200 mg per capsule, packaged in cartons, Rx only, Manufactur
2026-03-11
Class III — Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
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FDA Drug Recall: Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT
2026-01-28
Class III — Failed PH Specifications
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FDA Drug Recall: Lanreotide Injection, 120 mg/0.5 mL, 0.5 mL per pre-filled syringe, For deep sub
2026-01-21
Class II — Presence of Particulate Matter.
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FDA Drug Recall: Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack car
2025-12-17
Class II — Failed stability specifications: Out of specification for hardness test
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FDA Drug Recall: Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle, Rx Only, Manufac
2025-12-17
Class II — CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
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FDA Drug Recall: Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufac
2025-12-17
Class II — CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
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FDA Drug Recall: Lanthanum Carbonate chewable tablets, 1000mg*, 10x9 bottles per patient pack car
2025-12-17
Class II — Failed stability specifications: Out of specification for hardness test
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FDA Drug Recall: Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufac
2025-12-17
Class II — CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
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FDA Drug Recall: Albuterol Sulfate, Inhalation Aerosol, 90 mcg, 200 metered Inhalations, NET CONT
2025-08-27
Class III — 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.
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FDA Drug Recall: Budesonide Inhalation Suspension, 0.5mg/2ml, 30 single-dose ampules per carton,
2025-07-30
Class II — Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
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FDA Drug Recall: Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufact
2024-11-20
Class II — Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
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FDA Drug Recall: Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufact
2024-11-20
Class II — Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.
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FDA Drug Recall: Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/
2024-05-01
Class II — Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
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FDA Drug Recall: Albuterol Sulfate Inhalation Aerosol, 90 mcg, 200 Metered Inhalation, net conten
2023-07-19
Class I — Defective container: empty inhaler and leakage observed through the inhaler valve due to partially missing bottom seat (gasket).
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fda_adverse
5 records
FDA AE Manufacturer: Cipla USA, Inc.
Drug adverse event reporter — Product: DILTIAZEM HYDROCHLORIDE
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FDA AE Manufacturer: Cipla USA, Inc
Drug adverse event reporter — Product: OSELTAMIVIR PHOSPHATE
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FDA AE Manufacturer: Cipla USA., Inc.
Drug adverse event reporter — Product: BUPROPION HYDROCHLORIDE
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ny_corps
1 records
NY Corp: CIPLA USA INC.
2019-10-21
FOREIGN BUSINESS CORPORATION | County: Albany | Jurisdiction: Delaware
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