FDAFDA · Alimentos y medicamentos·N.º oficial D-0423-2019
Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-01
Publicado el 6 de febrero de 2019 · Inicio del retiro: 9 de enero de 2019
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; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Marca
- CEPHALEXIN
- Fabricante
- Lupin Pharmaceuticals Inc.
- Distribuidor
- Product was distributed to 5 wholesalers, 2 drug chains and 1 supermarket who may have further distributed the product throughout the United States.
- Lote
- lot F801282, Expiry June 2020
- Clasificación de riesgo
- Class II
- Área (FDA)
- drug
- País
- United States
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