Perfil del fabricante
Cariba International
Compañía farmacéutica3 productos registrados
3
productos registrados
113.143
notificaciones totales
189
retiradas registradas
92,6%
graves en total
Productos
mostrando 3 de 3
| Producto | Aprobado | Notificaciones ↓ | Señal principal | Retiradas |
|---|---|---|---|---|
| 1946 | 46.199 | Infección por Helicobacter | 100 | |
| — | 33.499 | Perforación de úlcera duodenal | 18 | |
| 2000 | 33.445 | Perforación de úlcera duodenal | 71 |
Historial de retiradas · 50 registradas
| Fecha | Clase | Motivo | Empresa |
|---|---|---|---|
| 22 abr 2026 | II | Lack of assurance of Sterility: potential product contamination | CareFusion 213, LLC |
| 22 abr 2026 | II | Lack of assurance of Sterility: potential product contamination | CareFusion 213, LLC |
| 2 mar 2026 | I | Non-Sterility: microbial contamination identified as Paenibacillus phoenicis | Cardinal Health 200, LLC |
| 20 ene 2026 | II | CGMP Deviations | ACME UNITED CORPORATION |
| 20 ene 2026 | II | CGMP Deviations | ACME UNITED CORPORATION |
| 26 dic 2025 | II | CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center. | GOLD STAR DISTRIBUTION INC |
| 29 sept 2025 | II | Subpotent Drug | Medline Industries, LP |
| 29 sept 2025 | II | cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded. | Acuity Specialty Products, Inc. |
| 25 ago 2025 | III | Cross Contamination with Other Products. | Consumer Product Partners, LLC |
| 25 ago 2025 | III | Cross Contamination with Other Products. | Consumer Product Partners, LLC |
| 7 jul 2025 | II | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield |
| 7 jul 2025 | II | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield |
| 7 jul 2025 | II | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield |
| 7 mar 2025 | II | Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol | Consumer Product Partners, LLC |
| 17 feb 2025 | II | Subpotent Drug | MEDLINE INDUSTRIES, LP - Northfield |
| 12 feb 2025 | II | Lack of assurance of sterility and cGMP deviations observed at the manufacturing site. | Wuxi Medical lnstrument Factory Co., Ltd. |
| 18 sept 2024 | II | CGMP deviations | EnviroServe Chemicals Inc. |
| 8 ago 2024 | II | Superpotent Drug | Teva Pharmaceuticals USA, Inc |
| 5 ago 2024 | II | CGMP Deviations: sterile water not used for production | Zeco LLC |
| 5 ago 2024 | II | CGMP Deviations: sterile water not used for production | Zeco LLC |
| 23 mar 2024 | I | Chemical Contamination: Product manufactured with ethanol API that contains methanol | Aruba Aloe Balm N.V. |
| 13 nov 2023 | I | Non-Sterility | Kilitch Healthcare India Limited |
| 31 oct 2023 | I | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. | Cardinal Health Inc. |
| 18 oct 2023 | II | CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts. | Integrity Bio-Chemicals LLC |
| 25 ago 2023 | II | Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides. | CareFusion 213, LLC |
| 26 abr 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| 20 abr 2023 | I | Product mix-up: incorrect product was found inside the G-Supress DX product carton. | Novis PR, LLC dba Kramer Novis |
| 27 mar 2023 | II | CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products. | Jarman's Midwest Cleaning Systems, Inc. |
| 23 feb 2023 | II | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Nutraceutical Corporation |
| 14 feb 2023 | I | Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits. | Nanomaterials Discovery Corporation |
| 17 ene 2023 | II | CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022. | Fisher Scientific Co., LLC |
| 17 ene 2023 | II | CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022. | Fisher Scientific Co., LLC |
| 17 ene 2023 | II | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. | Urban Electric Power |
| 15 dic 2022 | II | cGMP Deviations | Frenda Corporation |
| 15 dic 2022 | II | cGMP Deviations | Frenda Corporation |
| 15 dic 2022 | II | cGMP Deviations | Frenda Corporation |
| 15 dic 2022 | II | cGMP Deviations | Frenda Corporation |
| 9 dic 2022 | II | CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits. | NCH Life Sciences LLC |
| 5 nov 2022 | I | Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER isopropyl alcohol 75% v/v to contain methanol. | Adam's Polishes LLC |
| 5 nov 2022 | II | CGMP Deviations: Other lots of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol. | Adam's Polishes LLC |
| 6 oct 2022 | II | CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent. | Southwest Iowa Renewable Energy LLC |
| 14 sept 2022 | I | Chemical Contamination: product found to contain benzene | Salon Technologies International Inc |
| 15 ago 2022 | II | Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process. | Ultra Chem Labs Corp |
| 19 jul 2022 | II | Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol | Tsm Brands LLC |
| 19 jul 2022 | II | Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol | Tsm Brands LLC |
| 23 jun 2022 | II | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. |
| 15 jun 2022 | II | Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening. | Vi-Jon, LLC |
| 5 abr 2022 | II | CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits. | Lula Holdings L.L.C. |
| 3 mar 2022 | I | Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol. | Tennessee Technical Coatings, Corp. |
| 3 mar 2022 | II | CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol. | Tennessee Technical Coatings, Corp. |
Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.
Estado de registro
Algunos productos de Cariba International 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.