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Potential metal fragments from supplier raw material (downstream recall)
Potential presence of foreign material (metal) in the product
Undeclared sulfites in product label.
Possible stainless steel pieces in product.
Potential contamination with foreign objects.
Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient.
Presence of Particulate Matter: Particulate matter identified as glass
The potential contamination with Clostridium botulinum, due to risk of temperature abuse during chilled storage at the firm.
Pecan Caramel Clusters may contain undeclared cashews.
Subpotent Drug
cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was not performed, so methanol risk could not be excluded.
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Potential contamination with listeria monocytogenes
Contains elevated levels of lead
Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
potential for metal in product