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Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
Subpotent Drug; Ethinyl Estradiol
The firm is voluntarily recalling one lot of Guar Gum due to due to the inclusion of a misidentified ingredient, hydroxyethylcellulose.
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Superpotent and Subpotent drugs
Product contains a spice which was tested and found to contain elevated levels of lead.
Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry).
Labeling: Incorrect or Missing Lot and/or Exp Date: Bottles were incorrectly labeled with an expiry date of 11/17; the correct date is 09/17.
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.