Profil du fabricant
Caplin Steriles Limited
Société pharmaceutique2 produits suivis
2
produits suivis
52 151
total des notifications
10
rappels enregistrés
63,1%
graves au total
Produits
affichage de 2 sur 2
| Produit | Approuvé | Notifications ↓ | Signal principal | Rappels |
|---|---|---|---|---|
| 1992 | 45 392 | Migraine | 9 | |
| — | 6 759 | Douleur tendineuse | 1 |
Historique des rappels · 9 enregistrés
| Date | Classe | Motif | Fabricant |
|---|---|---|---|
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 13 avr. 2022 | II | cGMP deviations: Temperature abuse | Mckesson Medical-Surgical Inc. Corporate Office |
| 26 déc. 2019 | II | Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance. | Sun Pharmaceutical Industries, Inc. |
| 26 déc. 2019 | II | Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance. | Sun Pharmaceutical Industries, Inc. |
| 9 févr. 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 févr. 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. |
Classe I = probabilité raisonnable de préjudice grave · Classe II = temporaire ou réversible · Classe III = peu susceptible de causer un préjudice.
Statut d'enregistrement
Certains produits de Caplin Steriles Limited ne sont pas enregistrés auprès de la FDA pour un usage humain. Pour les substances non enregistrées (peptides, SARMs sans enregistrement humain), aucun fournisseur légitime à usage humain n'existe. L'absence de filière d'approvisionnement est l'information de sécurité.