Cipla USA Inc.,

Farmaceutisch bedrijf2 producten gevolgd

producten gevolgd

597.398

totaal meldingen

105

recalls geregistreerd

71,1%

ernstig algeheel

Producten

2 van 2 getoond

Product	Goedgekeurd	Meldingen ↓	Top signaal	Recalls
calcium —	1982	592.039	diabetes type 2	100
calcium acetate —	1982	5.359	chronische nierziekte-mineraal- en botstoornis	5

Recall-geschiedenis · 50 geregistreerd

Datum	Klasse	Reden	Bedrijf
30 jul 2025	II	Lack of Assurance of Sterility	GenoGenix LLC
2 okt 2023	II	Lack of Assurance of Sterility	Pine Pharmaceuticals, LLC
17 aug 2023	II	Lack of Assurance of Sterility:Lack of validation data for sanitization cycles	Central Admixture Pharmacy Services, Inc.
17 aug 2023	II	Lack of Assurance of Sterility:Lack of validation data for sanitization cycles	Central Admixture Pharmacy Services, Inc.
11 aug 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 apr 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 apr 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 apr 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 apr 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 dec 2022	II	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Pharmacy Innovations
22 dec 2022	II	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.	Pharmacy Innovations
18 mei 2022	II	Lack of Assurance of Sterility	Nephron Sterile Compounding Center LLC
16 mrt 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 apr 2021	II	Lack of Assurance of Sterility	Teva Pharmaceuticals USA
15 mrt 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 dec 2015	III	Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.	National Vitamin Co Inc
19 okt 2015	II	Lack of Assurance of Sterility	Western Drug
13 aug 2015	II	Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process.	GlaxoSmithKline, LLC.
13 aug 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 mei 2015	II	Lack of Assurance of Sterility: Sterility of product is not assured.	Lincare, Inc.
28 mei 2015	II	Lack of Assurance of Sterility: Sterility of product is not assured.	Lincare, Inc.
8 jan 2015	III	Subpotent Drug	Freedom Pharmaceuticals Inc
17 dec 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
17 dec 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
17 dec 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
17 dec 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
17 dec 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
17 dec 2014	I	Non-Sterility: Out of specification results for the sterility test for microbial contamination.	Central Admixture Pharmacy Services, Inc.
17 dec 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 aug 2014	I	Presence of Particulate Matter: particulate matter was found during the manufacturing process.	Baxter Healthcare Corp.
14 apr 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 okt 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 aug 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.

Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.

Registratiestatus

Sommige producten van Cipla USA Inc., zijn niet FDA-geregistreerd voor humaan gebruik. Voor ongeregistreerde stoffen (peptiden, SARMs zonder humane registratie) bestaat geen legitieme leverancier voor humaan gebruik. Het ontbreken van een inkooproute is de veiligheidsinformatie.