Herstellerprofil
Caplin Steriles Limited
Pharmaunternehmen2 erfasste Produkte
2
erfasste Produkte
52.151
Meldungen insgesamt
10
dokumentierte Rückrufe
63,1%
schwerwiegend insgesamt
Produkte
2 von 2 angezeigt
| Produkt | Zugelassen | Meldungen ↓ | Top-Signal | Rückrufe |
|---|---|---|---|---|
| 1992 | 45.392 | Migräne | 9 | |
| — | 6.759 | Sehnenschmerzen | 1 |
Rückrufhistorie · 9 dokumentiert
| Datum | Klasse | Grund | Firma |
|---|---|---|---|
| 13. Apr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13. Apr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 26. Dez. 2019 | II | Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance. | Sun Pharmaceutical Industries, Inc. |
| 26. Dez. 2019 | II | Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance. | Sun Pharmaceutical Industries, Inc. |
| 9. Feb. 2018 | II | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC |
| 9. Feb. 2018 | II | CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system. | American Pharmaceutical Ingredients LLC |
| 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 |
| 6. Nov. 2013 | II | Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield. | GlaxoSmithKline, LLC. |
| 6. Nov. 2013 | II | Lack of Assurance of Sterility: A small number of pre-filled syringes may contain needles which protrude through the needle shield. | GlaxoSmithKline, LLC. |
Klasse I = begründete Wahrscheinlichkeit schwerwiegender Schäden · Klasse II = vorübergehend oder reversibel · Klasse III = Schaden unwahrscheinlich.
Registrierungsstatus
Einige Produkte von Caplin Steriles Limited 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.