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Foreign Material (wood)
Misbranding of the ingredient the firm sells ( Passionflower Herb Extract )
Undeclared egg.
Insulin pumps manufactured with speakers from Revision A and B may malfunction ("Malfunction 16") which prevents audible alerts and causes the pumps to become inoperable and stop infusing insulin which could result in a hyperglycemic event, which may lead to injury and/or hospitalization.
Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
cGMP Deviations
Various snack cracker products are mislabeled and do not declare all allergen ingredients (Whole Milk Powder and wheat).
Incorrect ingredient was received from supplier and used in manufacturing finished product Relaxation Tea.
Potential contamination with Listeria monocytogenes
Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.
Failed Dissolution Specifications: low dissolution results
Contaminated with elevated lead and cadmium
The potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.