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Marketed without approved NDA/ANDA- Laboratory analysis found product to be tainted with undeclared ingredients: Dexamethasone and Diclofenac.
Lack of Assurance of Sterility
Due to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract.
Salmonella. The firm received cucumbers produced by Bedner Farms.
Salmonella. Greek Salad Kit made with recalled cucumbers sourced from Bedner Grower's Company which may be contaminated with Salmonella and implicated in an ongoing outbreak.
Cucumbers have the potential to be contaminated with Salmonella
Undeclared Milk Allergen
Required inspections were not performed on finished product prior to release and distribution.
BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.
Multiple plate failures documented as a result of the Low Positive Template Control being too high and out of range using the affected lot of ColoSense Test Kit.
Product contaminated with Salmonella
Cucumbers have the potential to be contaminated with Salmonella.
Product is contaminated with Salmonella
Potential to be contaminated with Salmonella