Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
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Drugs Recalls
Prescription and over-the-counter medications
17,685 Total Recalls
Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-997-15.
Nephron Sterile Compounding Center
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-305-10.
Nephron Sterile Compounding Center
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL (16 mcg/mL*), 250 mL Single-Dose Container bottle, packaged in 15 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-319-25.
Nephron Sterile Compounding Center
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Class I - Dangerous
Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Class I - Dangerous
Subpotent Drug
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL (32 mcg/mL*), 250 mL Single-Dose Container, packaged in 15 x 1 IV Bottles per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-316-25.
Nephron Sterile Compounding Center
Class I - Dangerous
Lack of Assurance of Sterility
Class I - Dangerous
CGMP Deviations: recalling drug products following an FDA inspection.