Prescription and over-the-counter medications
Ace Surgical Supply Co.
Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag
Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum.
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
Lack Of Assurance Of Sterility.
SCA Pharmaceuticals
Lack Of Assurance Of Sterility.
Subpotent Drug: low out of specification results.
Lack Of Assurance Of Sterility.
Lack Of Assurance Of Sterility.
Lack Of Assurance Of Sterility.
Lack Of Assurance Of Sterility.
Lack Of Assurance Of Sterility.
SCA Pharmaceuticals
Lack Of Assurance Of Sterility.
Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Lack Of Assurance Of Sterility.
SCA Pharmaceuticals
Lack Of Assurance Of Sterility.
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
Subpotent Drug
Banner Pharmacy Services
Lack of Assurance of Sterility.
Subpotent Drug