FDAFDA · Alimentos y medicamentos·N.º oficial D-0349-2021
ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution -Clear, 0.10 fl. oz. (3ml) each, 25 applicators per carton, applicator is sterile if package is intact. CareFusion El Paso, TX 79912, NDC 054365-400-01 Cat. No. 260400
Publicado el 5 de mayo de 2021 · Inicio del retiro: 19 de marzo de 2021
Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
CGMP Deviations: Product is being recalled because at labeled storage conditions of 30*C/75% Relative Humidity, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Qué hacer
Voluntary: Firm initiated · Press Release
Detalles del retiro
- Fabricante
- CareFusion 213, LLC
- Distribuidor
- Distributed Nationwide in the USA and to Singapore, Chile, Oman, Columbia, United Arab Emirates, South Africa, Kuwait, Democratic Republic of the Congo, Qatar, Bahrain, Hong Kong, Brazil.
- Lote
- Lot and Exp Date: 0000192, 12/31/2022; 0007621, 12/31/2022; 0008775, 12/31/2022; 0009111, 12/31/2022; 0011738, 12/31/2022; 0011753, 12/31/2022; 0011754, 12/31/2022; 0011755, 12/31/2022; 0013604, 12/31/2022; 0015498, 12/31/2022; 0015500, 12/31/2022; 0016329, 1/31/2023; 0017929, 12/31/2022; 0021945, 1/31/2023; 0028887, 1/31/2023; 0031093, 1/31/2023; 0034660, 1/31/2023; 0035149, 1/31/2023; 0036460, 1/31/2023; 0037272, 1/31/2023; 0038213, 1/31/2023; 0038217, 1/31/2023; 0041893, 1/31/2023; 0042483, 1/31/2023; 0042501, 1/31/2023; 0043105, 1/31/2023; 0044739, 1/31/2023; 0094838, 2/28/2023; 0098051, 2/28/2023; 0104859, 3/31/2023; 0129330, 4/30/2023; 0133069, 4/30/2023; 0220728, 7/31/2023; 0223036, 7/31/2023; 8078998, 3/31/2021; 8079620, 3/31/2021; 8079621, 3/31/2021; 8082921, 3/31/2021; 8082923, 3/31/2021; 8085804, 3/31/2021; 8088708, 3/31/2021; 8089621, 3/31/2021; 8093619, 3/31/2021; 8093813, 3/31/2021; 8094833, 3/31/2021; 8096706, 3/31/2021; 8097822, 3/31/2021; 8099727, 3/31/2021; 8099783, 3/31/2021; 8100947, 3/31/2021; 8101636, 3/31/2021; 8101719, 3/31/2021; 8102691, 3/31/2021; 8103673, 4/30/2021; 8108795, 4/30/2021; 8109707, 4/30/2021; 8110645, 4/30/2021; 8110674, 4/30/2021; 8114540, 4/30/2021; 8114547, 4/30/2021; 8115574, 4/30/2021; 8116705, 4/30/2021; 8120701, 4/30/2021; 8120985, 4/30/2021; 8122873, 4/30/2021; 8122874, 4/30/2021; 8124914, 4/30/2021; 8127649, 4/30/2021; 8127650, 4/30/2021; 8129680, 4/30/2021; 8129686, 4/30/2021; 8134847, 4/30/2021; 8134850, 4/30/2021; 8136811, 5/31/2021; 8137525, 5/31/2021; 8138867, 5/31/2021; 8141821, 5/31/2021; 8143659, 5/31/2021; 8144768, 5/31/2021; 8144882, 5/31/2021; 8145889, 5/31/2021; 8150625, 5/31/2021; 8151713, 5/31/2021; 8151736, 5/31/2021; 8152581, 5/31/2021; 8156507, 5/31/2021; 8156735, 5/31/2021; 8157866, 5/31/2021; 8157993, 5/31/2021; 8158595, 5/31/2021; 8158633, 5/31/2021; 8159995, 5/31/2021; 8164525, 6/30/2021; 8165696, 6/30/2021; 8167970, 6/30/2021; 8170535, 6/30/2021; 8170538, 6/30/2021; 8171503, 6/30/2021; 8172910, 6/30/2021; 8173655, 6/30/2021; 8176731, 6/30/2021; 8177746, 6/30/2021; 8178576, 6/30/2021; 8178654, 6/30/2021; 8179928, 6/30/2021; 8179974, 6/30/2021; 8180627, 6/30/2021; 8186700, 6/30/2021; 8190916, 6/30/2021; 8190987, 6/30/2021; 8192557, 6/30/2021; 8192881, 6/30/2021; 8197514, 6/30/2021; 8197515, 6/30/2021; 8198763, 7/31/2021; 8199675, 7/31/2021; 8204574, 7/31/2021; 8206898, 7/31/2021; 8211903, 7/31/2021; 8212879, 7/31/2021; 8214989, 7/31/2021; 8214995, 7/31/2021; 8215994, 7/31/2021; 8218645, 7/31/2021; 8219946, 7/31/2021; 8219988, 7/31/2021; 8222798, 7/31/2021; 8225863, 7/31/2021; 8225868, 7/31/2021; 8228632, 8/31/2021; 8229682, 8/31/2021; 8232739, 8/31/2021; 8233569, 8/31/2021; 8235983, 8/31/2021; 8239901, 8/31/2021; 8239902, 8/31/2021; 8240966, 8/31/2021; 8241848, 8/31/2021; 8243756, 8/31/2021; 8247510, 8/31/2021; 8248570, 8/31/2021; 8249934, 8/31/2021; 8257619, 8/31/2021; 8260778, 9/30/2021; 8261945, 9/30/2021; 8261946, 9/30/2021; 8262674, 9/30/2021; 8263865, 9/30/2021; 8265679, 9/30/2021; 8267928, 9/30/2021; 8267929, 9/30/2021; 8268617, 9/30/2021; 8268618, 9/30/2021; 8269913, 9/30/2021; 8271911, 9/30/2021; 8274999, 9/30/2021; 8275615, 9/30/2021; 8275625, 9/30/2021; 8276694, 9/30/2021; 8277635, 9/30/2021; 8277637, 9/30/2021; 8282884, 9/30/2021; 8283738, 9/30/2021; 8284622, 9/30/2021; 8285592, 9/30/2021; 8288852, 9/30/2021; 8290569, 9/30/2021; 8291769, 10/31/2021; 8292703, 10/31/2021; 8292708, 10/31/2021; 8296693, 10/31/2021; 8296695, 10/31/2021; 8299673, 10/31/2021; 8303606, 10/31/2021; 8304839, 10/31/2021; 8306692, 10/31/2021; 8309553, 10/31/2021; 8310641, 10/31/2021; 8311789, 10/31/2021; 8313646, 10/31/2021; 8313687, 10/31/2021; 8319821, 10/31/2021; 8320984, 11/30/2021; 8323514, 11/30/2021; 8323745, 11/30/2021; 8325725, 11/30/2021; 8325749, 11/30/2021; 8331695, 11/30/2021;
- Clasificación de riesgo
- Class II
- Área (FDA)
- drug
- País
- United States
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