Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is intended to dilate stenoses recall — FDA Z-0390-2019
Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
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Product may not meet the internal manufacturing shaft subassembly burst strength specification (Failure of the Burst Shaft Test).
The kit was provided without a copy of the lot-specific kit booklet and the Calibrator 0 vial 18D1/4 label incorrectly specified reconstitution volume of 2mL.
Potential for outer pouch sterile barrier to be compromised
The firm found what appeared to be plastic in the product.
Routine quality testing identified elevated levels of lead above applicable 2232 levels, which may pose potential health risks to a portion of the population.
Firm is recalling one lot of pistachios after customer tested product and had a positive result for Salmonella
The firm was notified by their supplier that ingredients used in their products were possibly contaminated with Listeria monocytogenes and Salmonella.
The firm was notified by their supplier that ingredients used in their products were possibly contaminated with Listeria monocytogenes and Salmonella.
During FDA inspection it was found that soy oil was not declared on package label
During FDA inspection it was found that soy oil was not declared on package label
During FDA inspection it was found that soy oil and coconut was not declared on package label.
The apple juice concentrates contain high levels of inorganic arsenic. The firm is recalling lots that were distributed for use other than fermentation (i.e. alcohol or vinegar).
Positive result for Salmonella received while investigating to determine supplier of direct customer's positive findings also for Salmonella
Frozen non-ready to eat Alaskan Salmon Bites, Kroger brand, are recalled due to potential contamination with Listeria monocytogenes or Salmonella in vegetables ingredient.
Hot & Sour Broth product contains Tamari which contains sub ingredient soybeans but finished label does not declare soy.
The firm was notified by their supplier that the vegetables used in the product were possibly contaminated with Listeria monocytogenes and Salmonella.
Cinnamon Chip Sourdough Village Baker brand was recalled because the label does not declare sub ingredients milk powder and soy lecithin.
During FDA inspection it was found that soy oil was not declared on package label
Angel Food Cake Bar was recalled due to undeclared milk and soy. The actual product inside container is corn breads and it was mislabeled as Angel Food Cake Bar.
Routine quality testing identified elevated levels of lead above applicable 2232 levels, which may pose potential health risks to a portion of the population.
Complaints of insects in product
Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date
Microbial Contamination of Non-Sterile Product
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
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