Herstellerprofil
Cipla USA Inc.,
Pharmaunternehmen2 erfasste Produkte
2
erfasste Produkte
597.398
Meldungen insgesamt
105
dokumentierte Rückrufe
71,1%
schwerwiegend insgesamt
Produkte
2 von 2 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| 1982 | 592.039 | Diabetes mellitus Typ 2 | 100 | |
| 1982 | 5.359 | Chronische Nierenerkrankung mit Mineral- und Knochenstoffwechselstörung | 5 |
Rückrufhistorie · 50 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 30. Juli 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. Juli 2023 | II | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. |
| 14. Juli 2023 | II | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. |
| 14. Juli 2023 | II | Lack of assurance of sterility. Validation data for decontamination cycles is lacking. | Central Admixture Pharmacy Services, Inc. |
| 23. Juni 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. Dez. 2022 | II | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations |
| 22. Dez. 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. März 2022 | III | Failed Impurities/Degradation Specifications: Out of Specification results for related substance. | Dr. Reddy's Laboratories, Inc. |
| 29. Juli 2021 | II | Lack of Assurance of Sterility | Teva Pharmaceuticals USA |
| 26. Apr. 2021 | II | Lack of Assurance of Sterility | Teva Pharmaceuticals USA |
| 15. März 2021 | II | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. |
| 19. Juni 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. Juli 2016 | II | Penicillin Cross Contamination | GlaxoSmithKline, LLC |
| 7. Juli 2016 | II | CGMP Deviations | Safecor Health, LLC |
| 20. Juni 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. Juni 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. Dez. 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. Juli 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. Jan. 2015 | III | Subpotent Drug | Freedom Pharmaceuticals Inc |
| 17. Dez. 2014 | I | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. |
| 17. Dez. 2014 | I | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. |
| 17. Dez. 2014 | I | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. |
| 17. Dez. 2014 | I | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. |
| 17. Dez. 2014 | I | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. |
| 17. Dez. 2014 | I | Non-Sterility: Out of specification results for the sterility test for microbial contamination. | Central Admixture Pharmacy Services, Inc. |
| 17. Dez. 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. Juli 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. |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von Cipla USA Inc., 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.