Drug recalls
627 recallsKetamine 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…
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…
Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag
Wells Pharma of Houston LLC
cGMP deviations.
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
Wells Pharma of Houston LLC
cGMP deviations.
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…
Optase Dry Eye Intense Drops (Glycerin 0.2%), packaged in 0.33 fl oz
SCOPE HEALTH
Lack of Assurance of Sterility
Levocarnitine Injection, USP, 1 g/5 mL (200 mg/mL)
American Regent, Inc.
Labeling: Missing Label
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL)
Harrow Eye LLC
Lack of Assurance of Sterility
Sterile Water for Injection USP, 3000 mL bags, Rx only
B BRAUN MEDICAL INC
Lack of Assurance of Sterility;
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram
The Harvard Drug Group LLC
Failed Capsule Specifications: Out of specification results obtained during routine stability tes…
Claravis (isotretinoin capsule, USP), 10 mg
Teva Pharmaceuticals USA, Inc
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg
Hetero Labs Limited (Unit V)
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than no…
Furosemide Tablets, USP, 80 mg, 100 Tablets bottles, Rx only
Leading Pharma, LLC
CGMP Deviations;
Premier, Monsel's, Ferric Subsulfate Solution, 8 mL bottles, Rx only
Premier Dental Products Co
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is…
LACTATED RINGER'S IRRIGATION, 3000 mL bags, Sterile, Ex only
B BRAUN MEDICAL INC
Lack of Assurance of Sterility;
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile
B BRAUN MEDICAL INC
Lack of Assurance of Sterility;
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile
B BRAUN MEDICAL INC
Lack of Assurance of Sterility;
exchange select, Menthol- Cough Suppressant Oral Anesthetic
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
This recall is being initiated following FDA's recommendation based on certain observations noted…
MGC Health, Menthol- Cough Suppressant, Oral Anesthetic, Cough Drops
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
This recall is being initiated following FDA's recommendation based on certain observations noted…
exchange select, Menthol -Cough Suppressant Oral Anesthetic
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
This recall is being initiated following FDA's recommendation based on certain observations noted…
QC Quality Choice, Menthol-Cough Suppressant Oral Anesthetic
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
This recall is being initiated following FDA's recommendation based on certain observations noted…
0.9% Sodium Chloride Injection, USP, 10 mL Ampules, Rx only
Huons Co., Ltd.
Lack of Assurance of Sterility
HydroPeptide CLEAR ALLIANCE SERUM, 2.5% BENZOYL PEROXIDE
Owen Biosciences Inc.
Chemical contamination: Presence of benzene
Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles
Island Kinetics, Inc. d.b.a. CoValence Laboratories
Failed Stability Specifications
Discount Drug Mart Food Market, Cough Drops
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
This recall is being initiated following FDA's recommendation based on certain observations noted…
Fluocinonide, USP, 0.05% Cream, 60g tube, Rx only
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in…
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle
Cipla USA, Inc.
CGMP Deviations;
SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%
Owen Biosciences Inc.
Chemical contamination: Presence of benzene