Drug recalls
500 recallsOasis Tears PF, Preservative-Free Lubricant Eye Drops
Oasis Medical, Inc.
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution foll…
Buprenorphine Hydrochloride, Injection, 0.3mg/mL
ENDO USA, Inc.
Crystallization;
Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tab…
Ascend Laboratories, LLC
Failed Dissolution Specifications
TPN bag (patient specific), Rx# 11-4909703-0-1
Central Admixture Pharmacy Services, Inc (CAPS) Los Angeles
Incorrect Product Formulation: product did not contain insulin as listed in the label.
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with…
CareFusion 213, LLC
Lack of assurance of Sterility: potential product contamination
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with…
CareFusion 213, LLC
Lack of assurance of Sterility: potential product contamination
Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules
Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 pp…
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only
Acella Pharmaceuticals, LLC
Chemical contamination;
Enalapril Maleate Tablets, USP, 20 mg, 1,000-count bottle, Rx only
JB Chemicals and Pharmaceuticals Ltd
Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impu…
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules
Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 pp…
busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only
Unichem Pharmaceuticals USA Inc.
Subpotent drug
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only
Breckenridge Pharmaceutical, Inc.
CGMP Deviations;
Lactated Ringer's Injection USP, 1000 mL container, Rx only
B BRAUN MEDICAL INC
Presence of Particulate Matter.
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-s…
Fresenius Medical Care Holdings, Inc.
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Octreotide Acetate for Injectable Suspension
Teva Pharmaceuticals USA, Inc
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food…
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-s…
Fresenius Medical Care Holdings, Inc.
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules
Ajanta Pharma Ltd.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 pp…
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%)
Thea Pharma, Inc.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by th…
Ketamine Hydrochloride Injectable Solution, 50mg/ml
Wells Pharma of Houston LLC
cGMP deviations.
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%)
Thea Pharma, Inc.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by th…
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
Wells Pharma of Houston LLC
cGMP deviations.
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride
Wells Pharma of Houston LLC
cGMP deviations.
GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz)
Alcon Research LLC
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact pr…
Alendronate Sodium Oral Solution, 70 mg/75 mL, 75 mL, Rx only
Hikma Pharmaceuticals USA INC
This recall is being conducted due to out of specification assay results in a limited number of b…
fentaNYL Citrate Injectable Solution, NARCOTIC, Cii
Wells Pharma of Houston LLC
cGMP deviations.
Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz
SCOPE HEALTH
Lack of Assurance of Sterility
fentaNYL Citrate Injectable Solution, Narcotic, CII
Wells Pharma of Houston LLC
cGMP deviations.
Lidocaine Wound Gel (Benzalkonium Chloride
Water-Jel Technologies, LLC
Failed PH Specifications
Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz)
Alcon Research LLC
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact pr…
Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag
Wells Pharma of Houston LLC
cGMP deviations.