Cipla USA Inc.,

Compañía farmacéutica2 productos registrados

productos registrados

597.398

notificaciones totales

105

retiradas registradas

71,1%

graves en total

Productos

mostrando 2 de 2

Producto	Aprobado	Notificaciones ↓	Señal principal	Retiradas
calcium —	1982	592.039	Diabetes mellitus tipo 2	100
calcium acetate —	1982	5359	Trastorno mineral y óseo de la enfermedad renal crónica	5

Historial de retiradas · 50 registradas

Fecha	Clase	Motivo	Empresa
30 jul 2025	II	Lack of Assurance of Sterility	GenoGenix LLC
2 oct 2023	II	Lack of Assurance of Sterility	Pine Pharmaceuticals, LLC
17 ago 2023	II	Lack of Assurance of Sterility:Lack of validation data for sanitization cycles	Central Admixture Pharmacy Services, Inc.
17 ago 2023	II	Lack of Assurance of Sterility:Lack of validation data for sanitization cycles	Central Admixture Pharmacy Services, Inc.
11 ago 2023	II	Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.	Baxter Healthcare Corporation
14 jul 2023	II	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Central Admixture Pharmacy Services, Inc.
14 jul 2023	II	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Central Admixture Pharmacy Services, Inc.
14 jul 2023	II	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Central Admixture Pharmacy Services, Inc.
23 jun 2023	I	Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test	Lupin Pharmaceuticals Inc.
28 abr 2023	II	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.	Central Admixture Pharmacy Services, Inc.
28 abr 2023	II	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.	Central Admixture Pharmacy Services, Inc.
28 abr 2023	II	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.	Central Admixture Pharmacy Services, Inc.
28 abr 2023	II	Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.	Central Admixture Pharmacy Services, Inc.
22 dic 2022	II	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Pharmacy Innovations
22 dic 2022	II	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Pharmacy Innovations
18 may 2022	II	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC
16 mar 2022	III	Failed Impurities/Degradation Specifications: Out of Specification results for related substance.	Dr. Reddy's Laboratories, Inc.
29 jul 2021	II	Lack of Assurance of Sterility	Teva Pharmaceuticals USA
26 abr 2021	II	Lack of Assurance of Sterility	Teva Pharmaceuticals USA
15 mar 2021	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
19 jun 2019	II	Lack of Assurance of Sterility	RXQ Compounding LLC
13 feb 2018	III	Presence of Foreign Tablets/Capsules	Nostrum Laboratories Inc
22 feb 2017	II	Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.	Advanced Pharma Inc.
18 nov 2016	II	Lack of Assurance of Sterility - the firm is recalling select sterile drug products.	Cantrell Drug Company
18 nov 2016	II	Lack of Assurance of Sterility - the firm is recalling select sterile drug products.	Cantrell Drug Company
18 jul 2016	II	Penicillin Cross Contamination	GlaxoSmithKline, LLC
7 jul 2016	II	CGMP Deviations	Safecor Health, LLC
20 jun 2016	II	Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.	W & C dba The Apothecary
20 jun 2016	II	Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.	W & C dba The Apothecary
18 dic 2015	III	Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.	National Vitamin Co Inc
19 oct 2015	II	Lack of Assurance of Sterility	Western Drug
13 ago 2015	II	Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.	GlaxoSmithKline, LLC.
13 ago 2015	II	Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.	GlaxoSmithKline, LLC.
24 jul 2015	II	Lack of Assurance of Sterility; all sterile human compounded drugs within expiry	JD & SN Inc., dba Moses Lake Professional Pharmacy
28 may 2015	II	Lack of Assurance of Sterility: Sterility of product is not assured.	Lincare, Inc.
28 may 2015	II	Lack of Assurance of Sterility: Sterility of product is not assured.	Lincare, Inc.
8 ene 2015	III	Subpotent Drug	Freedom Pharmaceuticals Inc
17 dic 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
17 dic 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
17 dic 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
17 dic 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
17 dic 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
17 dic 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
17 dic 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
14 nov 2014	II	Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.	Attix Pharmaceuticals
7 ago 2014	I	Presence of Particulate Matter: particulate matter was found during the manufacturing process.	Baxter Healthcare Corp.
14 abr 2014	II	Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Chemical analysis of the contaminant found on the cotton was identified as a formulation of 4% Trimipramine methanesulfonate - a tricyclic antidepressant..	Fresenius Medical Care Holdings, Inc.
19 oct 2013	II	Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.	Specialty Medicine Compounding Pharmacy
9 ago 2013	I	Non Sterility: Microbial contamination	Specialty Compounding, LLC
26 jul 2013	II	Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance	Beacon Hill Medical Pharmacy, P.C.

Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.

Estado de registro

Algunos productos de Cipla USA Inc., no están registrados por la FDA para uso humano. Para las sustancias no registradas (péptidos, SARM sin registro humano) no existe ningún proveedor legítimo para uso humano. La ausencia de una vía de aprovisionamiento es la información de seguridad.