Subpotent Drug: low Anti-Factor IIa potency.
All Recalls
95,094 total recalls in our database
CGMP DEVIATIONS
Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility.
Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-150-82
Denver Solutions, LLC
CGMP DEVIATIONS
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11
Denver Solutions, LLC
CGMP DEVIATIONS
Non-Sterility
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
CGMP DEVIATIONS
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Labeling: Not elsewhere classified
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
CGMP DEVIATIONS
CGMP DEVIATIONS
CGMP Deviations
Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15
Denver Solutions, LLC
CGMP DEVIATIONS
CGMP DEVIATIONS
Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO 80112, NDC 71449-148-94
Denver Solutions, LLC
CGMP DEVIATIONS
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Labeling: Incorrect or Missing Lot and/or Exp Date