Drugs & Medicine Recalls
Pharmaceutical recall notices, chemical impurities, and biological contamination.
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: A...
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alc...
Lack of assurance of Sterility: potential product contamination
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, 1000 mcg/50mL (20 ...
cGMP deviations.
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mc...
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.
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg...
cGMP deviations.
Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL...
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.
Lidocaine Wound Gel (Benzalkonium Chloride, 0.13% and Lidocaine Hydrochloride, 2...
Failed PH Specifications
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL), 5 mL Single-Dose Vial, For i...
Labeling: Missing Label
fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per m...
cGMP deviations.
Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma ...
cGMP deviations.
fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per...
cGMP deviations.
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.
Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz, Sterile, M...
Lack of Assurance of Sterility
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.
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only, Manufactur...
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that this error is limited to the vial itself; the saleable unit of the box of 12 bottles has the correct expiration date printed.
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only, Manufactured by: L...
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Sterile Water for Injection USP, 3000 mL bags, Rx only, Pharmacy Bulk Package, B...
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
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.
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx ...
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, ND...
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin