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.
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Drugs Recalls
Prescription and over-the-counter medications
17,302 Total Recalls
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
Class I - Dangerous
CGMP DEVIATIONS
Class I - Dangerous
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
Class I - Dangerous
CGMP DEVIATIONS
Class I - Dangerous
Non-Sterility
Class I - Dangerous
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class I - Dangerous
CGMP DEVIATIONS
Class I - Dangerous
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class I - Dangerous
Labeling: Not elsewhere classified
Class I - Dangerous
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class I - Dangerous
CGMP DEVIATIONS
Class I - Dangerous
CGMP DEVIATIONS
Class I - Dangerous
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
Class I - Dangerous
CGMP DEVIATIONS
Class I - Dangerous
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
Class I - Dangerous
CGMP DEVIATIONS
Class I - Dangerous
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date
Class I - Dangerous
CGMP DEVIATIONS
Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11.
Amerisource Health Services
Class I - Dangerous
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.