TRP The Relief Products* Gentle Eyes Lubricant Eye Drops
Lack of Assurance of Sterility
Updated
Drugs recalls
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AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops
Lack of Assurance of Sterility
Clear Eyes Redness Relief
Lack of Assurance of Sterility
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops
Lack of Assurance of Sterility
Lubricant Eye Drops-Cameron Pharmaceuticals
Lack of Assurance of Sterility
Reliable -1 Laboratories
Lack of Assurance of Sterility
Walgreens Lubricant Eye Drops
Lack of Assurance of Sterility
Exenatide Injection
Defective Delivery System: Possibility of no medication in the prefilled pen.
Olanzapine Tablets
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Major LubriFresh P.M
Lack of Assurance of Sterility
Walgreens Lubricant Eye Drops
Lack of Assurance of Sterility
Clear Eyes Redness Relief
Lack of Assurance of Sterility
Reliable-1 Laboratories Lubricating Tears
Lack of Assurance of Sterility
MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++, Net content
cGMP Deviations
Fluphenazine HCl Elixir
Failed Stability Specifications
Fluphenazine HCl Elixir
Failed Stability Specifications
Fluphenazine HCl Elixir
Failed Stability Specifications
Thyroid Tablets
Superpotent Drug
Fluphenazine HCl Elixir
Failed Stability Specifications
Fluphenazine HCl Elixir
Failed Stability Specifications
Fluphenazine HCl Elixir
Failed Stability Specifications
Lidocaine Ointment USP, 5%, Speermint Flavor
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
Chlorthalidone Tablets
Failed Dissolution Specifications
Dopamine HCl Inj., USP, 200 mg/5 mL (40 mg/mL)
Lack of Assurance of Sterility
fentaNYL Citrate
Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (1…
Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution
Subpotent Drug
Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility. Particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass and broken and lea…
Fluphenazine Hydrochloride Tablets
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent.…
Dextrose Injection
Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
0.9% Sodium Chloride Injection
Presence of Particulate Matter: particulate matter identified as iron oxide, inorganic material, cellulose cotton fiber or polystyrene
Clindamycin Injection USP in 5% Dextrose
CGMP Deviations
Vasopressin
CGMP Deviations
Daptomycin
CGMP Deviations
Glutathione 200 mg/mL, 30 mL sterile multidose vial
Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection
CGMP Deviations
Trokendi XR, (topiramate) extended-release capsules
Failed dissolution specifications.
Buprenorphine Sublingual Tablets (C-III)
Labeling: Label Mix-up
traZODone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules
0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers
Presence of particulate matter: Particulates identified as fiberglass
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%)
Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
FDA enforcement reports (food, drugs, medical devices), USDA FSIS (meat, poultry and eggs) and the CPSC (consumer products), last 45 days. Class I means the product could cause serious harm. Always confirm lot numbers on the official notice.