Herstellerprofil
Cariba International
Pharmaunternehmen3 erfasste Produkte
3
erfasste Produkte
113.143
Meldungen insgesamt
189
dokumentierte Rückrufe
92,6%
schwerwiegend insgesamt
Produkte
3 von 3 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| 1946 | 46.199 | Helicobacter-Infektion | 100 | |
| — | 33.499 | Perforation eines Zwölffingerdarmgeschwürs | 18 | |
| 2000 | 33.445 | Perforation eines Zwölffingerdarmgeschwürs | 71 |
Rückrufhistorie · 50 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 22. Apr. 2026 | II | Lack of assurance of Sterility: potential product contamination | CareFusion 213, LLC |
| 22. Apr. 2026 | II | Lack of assurance of Sterility: potential product contamination | CareFusion 213, LLC |
| 2. März 2026 | I | Non-Sterility: microbial contamination identified as Paenibacillus phoenicis | Cardinal Health 200, LLC |
| 20. Jan. 2026 | II | CGMP Deviations | ACME UNITED CORPORATION |
| 20. Jan. 2026 | II | CGMP Deviations | ACME UNITED CORPORATION |
| 26. Dez. 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. Aug. 2025 | III | Cross Contamination with Other Products. | Consumer Product Partners, LLC |
| 25. Aug. 2025 | III | Cross Contamination with Other Products. | Consumer Product Partners, LLC |
| 7. Juli 2025 | II | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield |
| 7. Juli 2025 | II | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield |
| 7. Juli 2025 | II | Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration. | MEDLINE INDUSTRIES, LP - Northfield |
| 7. März 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. Aug. 2024 | II | Superpotent Drug | Teva Pharmaceuticals USA, Inc |
| 5. Aug. 2024 | II | CGMP Deviations: sterile water not used for production | Zeco LLC |
| 5. Aug. 2024 | II | CGMP Deviations: sterile water not used for production | Zeco LLC |
| 23. März 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. Okt. 2023 | I | Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility. | Cardinal Health Inc. |
| 18. Okt. 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. Aug. 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. Apr. 2023 | II | CGMP Deviations: Firm went out of business and could no longer continue stability studies. | Akorn, Inc. |
| 20. Apr. 2023 | I | Product mix-up: incorrect product was found inside the G-Supress DX product carton. | Novis PR, LLC dba Kramer Novis |
| 27. März 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. Jan. 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. Jan. 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. Jan. 2023 | II | CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits. | Urban Electric Power |
| 15. Dez. 2022 | II | cGMP Deviations | Frenda Corporation |
| 15. Dez. 2022 | II | cGMP Deviations | Frenda Corporation |
| 15. Dez. 2022 | II | cGMP Deviations | Frenda Corporation |
| 15. Dez. 2022 | II | cGMP Deviations | Frenda Corporation |
| 9. Dez. 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. Okt. 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. Aug. 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. Juli 2022 | II | Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol | Tsm Brands LLC |
| 19. Juli 2022 | II | Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol | Tsm Brands LLC |
| 23. Juni 2022 | II | CGMP Deviations: product held outside appropriate storage temperature conditions. | Family Dollar Stores, Llc. |
| 15. Juni 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. Apr. 2022 | II | CGMP Deviations: FDA analysis found product to contain acetaldehyde above specification limits. | Lula Holdings L.L.C. |
| 3. März 2022 | I | Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol. | Tennessee Technical Coatings, Corp. |
| 3. März 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. |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von Cariba International sind nicht für die Anwendung am Menschen FDA-registriert. Für nicht registrierte Substanzen (Peptide, SARMs ohne Humanzulassung) existiert kein legitimer Anbieter für die Anwendung am Menschen. Das Fehlen eines Bezugswegs ist die Sicherheitsinformation.