GANCICLOVIR ( CYTOVENE) (a)1480MG IN NS 296ML, (b) 740 MG IN NS 336 ML, antiviral, Rx Only, use with a Curlin pump, Sentara Home…
Reason Lack of sterility assurance
9 FDA recalls mention Ganciclovir. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Ganciclovir.
Reason Lack of sterility assurance
Reason Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg.
Reason Presence of foreign substance: Brown/black particles found during stability testing.
Reason Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and…
Reason Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
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; container closure issues with the bulk batch.
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