Amikacin 450MG IN NS 45ML, Antibiotic, used in a HOMEPUMP, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300 Chesapeake, VA 23320,
Sentara Infusion Services
Class I - Dangerous
Lack of sterility assurance
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Compounded Drugs
💊 Drugs • 1,903 recalls
Class I - Dangerous
Short Fill
Class I - Dangerous
Short Fill
Class I - Dangerous
CGMP Deviations:
Class I - Dangerous
CGMP Deviations:
Class I - Dangerous
CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits.
Class I - Dangerous
CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
Class I - Dangerous
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Systane Zaditor, ketotifen fumarate ophthalmic solution 0.035%, Antihistamine eye drops, Eye Itch Relief, up to 12 Hours, Sterile, 30 day supply, 5mL (0.17 FL OZ) bottle per box, Alcon, NDC 0065-4011-05.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
GenTeal Tears, Lubricant Eye Ointment, Night-Time Ointment, Sterile, 3.5 gm (0.12 FL OZ) per box, Alcon, NDC 0065-0518-01.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Eye-stream, eye wash solution, sterile, 4 FL OZ (118 mL) bottle per box, Alcon, NDC 0065-0530-04.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Class I - Dangerous
Lack of Assurance of Sterility: Complaints received of defective container closure.
Naphcon A eye drops, Naphazoline HCl 0.025% and Pheniramine Maleate 0.3%, Redness Reliever and Antihistamine Eye Drops, Sterile, 15 mL (0.5 FL OZ) bottle per box, Alcon, a Novartis company, NDC 0065-0085-15.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Systane, Lubricant Eye Drops, Polyethylene Glycol 400 0.4% Lubricant, Propylene Glycol 0.3% Lubricant, Original, Long Lasting Dry Eye Relief, Sterile, a) 15 mL (0.5 FL OZ) NDC 0065-0429-15, b) 30 mL (1 FL OZ) NDC 0065-0429-30, bottle per box, Alcon Surgical Inc.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Systane Balance, Lubricant Eye Drops, Propylene Glycol 0.6% lubricant, Restorative Formula, Sterile, 10 mL (1/3 FL OZ) bottle per box, Alcon, NDC 0065-1433-02.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Sterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16.
Mckesson Medical-Surgical Inc. Corporate Office
Class I - Dangerous
CGMP Deviations: products were stored outside the drug label specifications.
Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.
GAC (Glutamine/Arginine/L-Carnitine) 25mg/100mg/250mg/mL, 30mL-vial, Refrigerate, Tailor Made Compounding
TMC Acquisition LLC
Class I - Dangerous
Lack of Assurance of Sterility
Estradiol Cypionate 10mg/mL, a) 1mL-vial, b) 2 mL-vial, Room Temperature, Tailor Made Compounding
TMC Acquisition LLC
Class I - Dangerous
Lack of Assurance of Sterility
Semaglutide/Cyanocobalamin 5mg/0.2mg/ml, 2ml-vial, Refrigerate, Tailor Made Compounding
TMC Acquisition LLC
Class I - Dangerous
Lack of Assurance of Sterility