Drug recalls
500 recallsLevocarnitine Injection, USP, 1 g/5 mL (200 mg/mL)
American Regent, Inc.
Labeling: Missing Label
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
Wells Pharma of Houston LLC
cGMP deviations.
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…
FRESHKOTE LUBRICANT EYEDROPS, Sterile, 0.33 FL OZ (10mL)
Harrow Eye LLC
Lack of Assurance of Sterility
DEXTROSE INJECTION USP, 70%, 2000 mL bags, Rx only, Sterile
B BRAUN MEDICAL INC
Lack of Assurance of Sterility;
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;
Claravis (isotretinoin capsule, USP), 10 mg
Teva Pharmaceuticals USA, Inc
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
0.9 % SODIUM CHLORIDE IRRIGATION, USP, 3000 mL bags, Rx only, Sterile
B BRAUN MEDICAL INC
Lack of Assurance of Sterility;
Sterile Water for Injection USP, 3000 mL bags, Rx only
B BRAUN MEDICAL INC
Lack of Assurance of Sterility;
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…
Fluocinonide, USP, 0.05% Cream, 30g tube, Rx only
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in…
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…
FHF Farmhouse Fresh, Midnight Clearing, NIGHT LOTION
Owen Biosciences Inc.
Chemical contamination: Presence of benzene
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…
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…
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…
Remedy Gel, hydrocortisone 1%, 30 mL/ 1 fl oz per bottle
Island Kinetics, Inc. d.b.a. CoValence Laboratories
Subpotent Drug
Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML
PAYLESS COMPOUNDERS, LLC
Lack of Assurance of Sterility
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle
Cipla USA, Inc.
CGMP Deviations;
Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5 mL bottle (50 doses)
Apotex Corp.
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missin…
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only
International Medication Systems Ltd.
Lack of Assurance of Sterility
SLMD BP Acne Spot Treatment, 10% Benzoyl Peroxide
Owen Biosciences Inc.
Chemical contamination: Presence of benzene
Essential Calming Skin Gel, hydrocortisone 1%
Island Kinetics, Inc. d.b.a. CoValence Laboratories
Subpotent Drug
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;
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…
Albuterol Sulfate Inhalation Solution, 0.5%, 25 mg/5 mL (5 mg/mL*)
Nephron SC, LLC
Labelling: Illegible label
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…