Fabrikant-profiel
Caplin Steriles Limited
Farmaceutisch bedrijf2 producten gevolgd
2
producten gevolgd
52.151
totaal meldingen
10
recalls geregistreerd
63,1%
ernstig algeheel
Producten
2 van 2 getoond
| Product | Goedgekeurd | Meldingen ↓ | Top signaal | Recalls |
|---|---|---|---|---|
| 1992 | 45.392 | migraine | 9 | |
| — | 6.759 | Peespijn | 1 |
Recall-geschiedenis · 9 geregistreerd
| Datum | Klasse | Reden | Bedrijf |
|---|---|---|---|
| 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 dec 2019 | II | Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance. | Sun Pharmaceutical Industries, Inc. |
| 26 dec 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. |
Class I = redelijke kans op ernstige schade · Class II = tijdelijk of omkeerbaar · Class III = onwaarschijnlijk schadelijk.
Registratiestatus
Sommige producten van Caplin Steriles Limited zijn niet FDA-geregistreerd voor humaan gebruik. Voor ongeregistreerde stoffen (peptiden, SARMs zonder humane registratie) bestaat geen legitieme leverancier voor humaan gebruik. Het ontbreken van een inkooproute is de veiligheidsinformatie.