Profil du fabricant
Cariba International
Société pharmaceutique3 produits suivis
3
produits suivis
113 143
total des notifications
189
rappels enregistrés
92,6%
graves au total
Produits
affichage de 3 sur 3
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| 1946 | 46 199 | Infection à Helicobacter | 100 | |
| — | 33 499 | Perforation d'ulcère duodénal | 18 | |
| 2000 | 33 445 | Perforation d'ulcère duodénal | 71 |
Historique des rappels · 50 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 22 avr. 2026 | II | Lack of assurance of Sterility: potential product contamination | CareFusion 213, LLC |
| 22 avr. 2026 | II | Lack of assurance of Sterility: potential product contamination | CareFusion 213, LLC |
| 2 mars 2026 | I | Non-Sterility: microbial contamination identified as Paenibacillus phoenicis | Cardinal Health 200, LLC |
| 20 janv. 2026 | II | CGMP Deviations | ACME UNITED CORPORATION |
| 20 janv. 2026 | II | CGMP Deviations | ACME UNITED CORPORATION |
| 26 déc. 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 août 2025 | III | Cross Contamination with Other Products. | Consumer Product Partners, LLC |
| 25 août 2025 | III | Cross Contamination with Other Products. | Consumer Product Partners, LLC |
| 7 juil. 2025 | II | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield |
| 7 juil. 2025 | II | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield |
| 7 juil. 2025 | II | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield |
| 7 mars 2025 | II | Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol | Consumer Product Partners, LLC |
| 17 févr. 2025 | II | Subpotent Drug | MEDLINE INDUSTRIES, LP - Northfield |
| 12 févr. 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 août 2024 | II | Superpotent Drug | Teva Pharmaceuticals USA, Inc |
| 5 août 2024 | II | CGMP Deviations: sterile water not used for production | Zeco LLC |
| 5 août 2024 | II | CGMP Deviations: sterile water not used for production | Zeco LLC |
| 23 mars 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 août 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 avr. 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| 20 avr. 2023 | I | Product mix-up: incorrect product was found inside the G-Supress DX product carton. | Novis PR, LLC dba Kramer Novis |
| 27 mars 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 févr. 2023 | II | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Nutraceutical Corporation |
| 14 févr. 2023 | I | Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits. | Nanomaterials Discovery Corporation |
| 17 janv. 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 janv. 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 janv. 2023 | II | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. | Urban Electric Power |
| 15 déc. 2022 | II | cGMP Deviations | Frenda Corporation |
| 15 déc. 2022 | II | cGMP Deviations | Frenda Corporation |
| 15 déc. 2022 | II | cGMP Deviations | Frenda Corporation |
| 15 déc. 2022 | II | cGMP Deviations | Frenda Corporation |
| 9 déc. 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 août 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 juil. 2022 | II | Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol | Tsm Brands LLC |
| 19 juil. 2022 | II | Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol | Tsm Brands LLC |
| 23 juin 2022 | II | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. |
| 15 juin 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 avr. 2022 | II | CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits. | Lula Holdings L.L.C. |
| 3 mars 2022 | I | Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol. | Tennessee Technical Coatings, Corp. |
| 3 mars 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. |
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 Cariba International 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.