Drugs & Medicine Recalls
Pharmaceutical recall notices, chemical impurities, and biological contamination.
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alc...
Lack of assurance of Sterility: potential product contamination
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange ...
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. b...
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactu...
Subpotent drug
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange ...
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per m...
cGMP deviations.
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mc...
cGMP deviations.
Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only, 4 x 75 mL Single ...
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg...
cGMP deviations.
fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per...
cGMP deviations.
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in...
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 m...
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alc...
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma ...
cGMP deviations.
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 ...
cGMP deviations.
Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in Fran...
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL...
cGMP deviations.
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For i...
Labeling: Missing Label
Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2...
Failed PH Specifications
Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, M...
Lack of Assurance of Sterility
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose...
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile, B. Braun Medical In...
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only, B. Braun Medical I...
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL), Harrow Eye LLC, Nashvi...
Lack of Assurance of Sterility