5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
23 FDA recalls mention Fluorouracil. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Fluorouracil.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason Lack of Processing Control
Reason Presence of Particulate Matter; glass particulates
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
Reason Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Reason Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality…
Reason Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality…
Reason Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the…
Reason Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because…
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