FDAFDA · Alimentos y medicamentos·N.º oficial D-1510-2014
Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India.
Publicado el 13 de agosto de 2014 · Inicio del retiro: 26 de junio de 2014
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: These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices.
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- Caraco Pharmaceutical Laboratories, Ltd.
- Distribuidor
- Nationwide and Puerto Rico
- Lote
- Lot #: a) AGL0098B, AGL0099B, AGL0100B, AGL0101B, Exp 09/14; AGM0073B, AGM0074B, Exp 04/15; AGM0125B, AGM0126B, Exp 07/15; AGM0158B, Exp 09/15; b) AGL0092A, AGL0093A, AGL0094A, AGL0095A, AGL0096A, AGL0097A, AGL0102A, AGL0103A, AGL0104A, AGL0105A, Exp 09/14; AGM0067A, AGM0068A, AGM0069A, Exp 03/15; AGM0070A, AGM0071A, AGM0072A, AGM0085A, AGM0086A, Exp 04/15; AGM0127A, AGM0128A, AGM0129A, AGM0130A, AGM0131A, AGM0132A, Exp 07/15
- Clasificación de riesgo
- Class II
- Área (FDA)
- drug
- País
- United States
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