Cipla USA Inc.,

Société pharmaceutique2 produits suivis

produits suivis

597 398

total des notifications

105

rappels enregistrés

71,1%

graves au total

Produits

affichage de 2 sur 2

Produit	Approuvé	Notifications ↓	Signal principal	Rappels
calcium —	1982	592 039	Diabète de type 2	100
calcium acetate —	1982	5 359	Maladie rénale chronique - trouble minéral et osseux	5

Historique des rappels · 50 enregistrés

Date	Classe	Motif	Fabricant
30 juil. 2025	II	Lack of Assurance of Sterility	GenoGenix LLC
2 oct. 2023	II	Lack of Assurance of Sterility	Pine Pharmaceuticals, LLC
17 août 2023	II	Lack of Assurance of Sterility:Lack of validation data for sanitization cycles	Central Admixture Pharmacy Services, Inc.
17 août 2023	II	Lack of Assurance of Sterility:Lack of validation data for sanitization cycles	Central Admixture Pharmacy Services, Inc.
11 août 2023	II	Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.	Baxter Healthcare Corporation
14 juil. 2023	II	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Central Admixture Pharmacy Services, Inc.
14 juil. 2023	II	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Central Admixture Pharmacy Services, Inc.
14 juil. 2023	II	Lack of assurance of sterility. Validation data for decontamination cycles is lacking.	Central Admixture Pharmacy Services, Inc.
23 juin 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 avr. 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 avr. 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 avr. 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 avr. 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 déc. 2022	II	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Pharmacy Innovations
22 déc. 2022	II	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Pharmacy Innovations
18 mai 2022	II	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC
16 mars 2022	III	Failed Impurities/Degradation Specifications: Out of Specification results for related substance.	Dr. Reddy's Laboratories, Inc.
29 juil. 2021	II	Lack of Assurance of Sterility	Teva Pharmaceuticals USA
26 avr. 2021	II	Lack of Assurance of Sterility	Teva Pharmaceuticals USA
15 mars 2021	II	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	Cardinal Health Inc.
19 juin 2019	II	Lack of Assurance of Sterility	RXQ Compounding LLC
13 févr. 2018	III	Presence of Foreign Tablets/Capsules	Nostrum Laboratories Inc
22 févr. 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 juil. 2016	II	Penicillin Cross Contamination	GlaxoSmithKline, LLC
7 juil. 2016	II	CGMP Deviations	Safecor Health, LLC
20 juin 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 juin 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 déc. 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 août 2015	II	Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.	GlaxoSmithKline, LLC.
13 août 2015	II	Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.	GlaxoSmithKline, LLC.
24 juil. 2015	II	Lack of Assurance of Sterility; all sterile human compounded drugs within expiry	JD & SN Inc., dba Moses Lake Professional Pharmacy
28 mai 2015	II	Lack of Assurance of Sterility: Sterility of product is not assured.	Lincare, Inc.
28 mai 2015	II	Lack of Assurance of Sterility: Sterility of product is not assured.	Lincare, Inc.
8 janv. 2015	III	Subpotent Drug	Freedom Pharmaceuticals Inc
17 déc. 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
17 déc. 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
17 déc. 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
17 déc. 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
17 déc. 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
17 déc. 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
17 déc. 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 août 2014	I	Presence of Particulate Matter: particulate matter was found during the manufacturing process.	Baxter Healthcare Corp.
14 avr. 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 août 2013	I	Non Sterility: Microbial contamination	Specialty Compounding, LLC
26 juil. 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.

Classe I = probabilité raisonnable de préjudice grave · Classe II = temporaire ou réversible · Classe III = peu susceptible de causer un préjudice.

Statut d'enregistrement

Certains produits de Cipla USA Inc., ne sont pas enregistrés auprès de la FDA pour un usage humain. Pour les substances non enregistrées (peptides, SARMs sans enregistrement humain), aucun fournisseur légitime à usage humain n'existe. L'absence de filière d'approvisionnement est l'information de sécurité.