Houston Rx Sermorelin and Tirzepatide/Niacinamide Injections
Sermorelin sterile injectable solution lacks process control, and Tirzepatide/Niacinamide injection lacks assurance of sterility.
2 productsSermorelin sterile injectable solution lacks process control, and Tirzepatide/Niacinamide injection lacks assurance of sterility.
2 productsTirzepatide Injection lacks assurance of sterility.
2 productsCarolina Infusion Tirzepatide, Semaglutide and Tri-Mix Injectables lack assurance of sterility.
16 productsArtificial Tears Sterile Lubricant Eye Drops lack assurance of sterility.
8 productsPHP Animal Health Pet Drops Lubricant Eye Drops lack assurance of sterility.
FOCUS PI Hypromellose 0.7% Formula lacks assurance of sterility.
Clear Eyes Redness Relief eye drops lack assurance of sterility.
2 productsAvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% lacks assurance of sterility.
9 productsDopamine HCl injection lacks assurance of sterility.
Apheresis PF24RT24 Plasma was collected in a manner that compromises the sterility of the collection system.
Glutathione, Myer's Cocktail, and Tri-Immune Boost injectable vials may contain elevated endotoxin levels, which could cause significant medical events.
3 productsPresence of Particulate Matter and Lack of Assurance of Sterility.
Glutathione 200 mg/mL sterile multidose vials have elevated bacterial endotoxin levels, which could cause significant medical events.
Libtayo (cemiplimab-rwlc) Injection lacks assurance of sterility.
CLEAR EYES Maximum Itchy Eye Relief lacks assurance of sterility and may be contaminated.
Compounded glutathione vials have elevated bacterial endotoxin levels, which could cause fever, hypotension, inflammatory reactions, anaphylactic shock.
BD ChloraPrep Clear may have an open or incomplete seal on the applicator packaging.
Cleviprex injectable emulsion lacks assurance of sterility.
Accucaine kits containing Lidocaine HCl Injection lack assurance of sterility.
2 productsBD ChloraPrep and PurPrep applicators may be unsterile or contaminated with fungus, potentially causing serious infection or death.
10 productsImuldosa injection lacks assurance of sterility.
PReye Vitamin See Antioxidant Preservative Free Eye Drops lack assurance of sterility.
Reason given by FDA: Microbial contamination of sterile products.
BD ChloraPrep Clear Applicators were recalled for lack of assurance of sterility or non-sterility.
4 productsLidocaine HCl Injection USP may lack sterility.
Cimzia (certolizumab pegol) prefilled syringes lack assurance of sterility.
Ophthavet Ophthalmic Solution has a potential quality concern at the manufacturing site.
Oasis Tears PF lubricant eye drops lack assurance of sterility.
Octreotide Acetate for Injectable Suspension lacks assurance of sterility due to quality system deficiencies.
BD PurPrep sterile solution may lack assurance of sterility due to potential contamination.
2 productsDelflex, Dextrose Peritoneal Dialysis Solution may have leaks from perforations in bags, lacking assurance of sterility.
2 productsFreshkote Lubricant Eyedrops lack assurance of sterility.
Optase Dry Eye Intense Drops lack assurance of sterility.
IVIZIA Sterile Lubricant Eye Drops lack assurance of sterility due to manufacturing deviations.
2 productsSystane Lubricant Eye Gel Night Gel may lack assurance of sterility.
2 productsSterile Water for Injection USP lacks assurance of sterility, which could cause leakage from the diaphragm port.
4 productsEpinephrine Injection lacks assurance of sterility.
Lidocaine HCl injection lacks assurance of sterility.
6 productsSemaglutide-Glycine-Cyanocobalamin Injectable lacks assurance of sterility.
Norepinephrine Bitartrate and Vancomycin injections lack assurance of sterility, and a blue part could detach from the port.
5 productsArtificial Tears Lubricant Eye Drops lack assurance of sterility.
Sodium chloride and dextrose injections lack assurance of sterility.
14 productsLanreotide Injection lacks assurance of sterility due to deficiencies in visual inspection.
2 productsCurosurf (poractant alfa) lacks assurance of sterility.
Octreotide Acetate for Injectable Suspension lacks assurance of sterility due to quality system deficiencies.
6 productsNoromycin 300 LA antibiotic lacks assurance of sterility.
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution lacks assurance of sterility.
Webcol Alcohol Prep pads may be non-sterile due to microbial contamination, posing an infection risk to vulnerable groups.
3 products