Perfil del fabricante
Caplin Steriles Limited
Compañía farmacéutica2 productos registrados
2
productos registrados
52.151
notificaciones totales
10
retiradas registradas
63,1%
graves en total
Productos
mostrando 2 de 2
| Producto | Aprobado | Notificaciones ↓ | Señal principal | Retiradas |
|---|---|---|---|---|
| 1992 | 45.392 | Migraña | 9 | |
| — | 6759 | Dolor en el tendón | 1 |
Historial de retiradas · 9 registradas
| Fecha | Clase | Motivo | Empresa |
|---|---|---|---|
| 13 abr 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 abr 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 26 dic 2019 | II | Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance. | Sun Pharmaceutical Industries, Inc. |
| 26 dic 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. |
Clase I = probabilidad razonable de daño grave · Clase II = temporal o reversible · Clase III = improbable que cause daño.
Estado de registro
Algunos productos de Caplin Steriles Limited 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.