Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Prescription Drugs
💊 Drugs • 12,141 recalls
Neostigmine Methylsulfate 5 mg/5 mL Injection Solution, 5 mL (1 mg/mL) Single-Dose Syringe, For Slow IV Use, Rx Only, Cantrell Drug Co. 7321 Cantrell Rd. Little Rock, AR 72207, NDC 52533-046-15
Cantrell Drug Company
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL), Single-Dose Syringe, Hospital/Office Use Only, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-001-04
Cantrell Drug Company
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Phenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL Single-Dose Syringe, Rx Only Cantrell Drug Company 7321 Cantrell Rd Little Rock, AR 72207, NDC 52533-171-12
Cantrell Drug Company
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride, 100 mL Bag, Single-Dose Bag, Rx Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-160-75
Cantrell Drug Company
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Calcium Chloride 1 g/50 mL* Added to 5% Dextrose (20 mg/mL)*, Single-Dose Bag, Rx Only, Hospital/Office Use Only, Cantrell Drug Co. 7321 Cantrell Road Little Rock, AR 72207, NDC 52533-175-37
Cantrell Drug Company
Lack of Assurance of Sterility - the firm is recalling select sterile drug products.
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.
PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.
Fallon Wellness Pharmacy, L.L.C.
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-210-13.
Teva Pharmaceuticals USA
Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.
PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.
Fallon Wellness Pharmacy, L.L.C.
Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-702-10.
Nationwide Laboratories
CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.
Lack of Assurance of Sterility; damage to the internal portion of the dropper tip portion of the container
Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10
Burel Pharmaceuticals
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures
Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10
Burel Pharmaceuticals
CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures