February 8, 2023DrugsFDA
Frenda Corporation recalls Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gallon (128 FL OZ) 3785.41 mL, Dist. by Target
Hazard: cGMP Deviations
February 8, 2023DrugsFDA
Frenda Corporation recalls Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00045 5; b) 16 fl. oz. (473 mL) UPC 8 91
Hazard: cGMP Deviations
February 8, 2023DrugsFDA
Frenda Corporation recalls Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00048 6; b) 16 fl. oz. (473 mL) UPC
Hazard: cGMP Deviations
February 8, 2023DrugsFDA
Frenda Corporation recalls Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, U
Hazard: cGMP Deviations
February 8, 2023DrugsFDA
Frenda Corporation recalls Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol, 32 FL. OZ. (946 mL.), Manufactured by: Frenda Co
Hazard: cGMP Deviations
February 8, 2023DrugsFDA
Frenda Corporation recalls Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (128 Fl. oz.), Manufactured by: Frenda Corpo
Hazard: cGMP Deviations
February 8, 2023DrugsFDA
GFA Production Xiamen Co. Ltd. recalls Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, P
Hazard: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
February 8, 2023DrugsFDA
GFA Production Xiamen Co. Ltd. recalls CVS First Aid Home, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 2980-0700
Hazard: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
February 8, 2023DrugsFDA
GFA Production Xiamen Co. Ltd. recalls Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, P
Hazard: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
February 8, 2023DrugsFDA
GFA Production Xiamen Co. Ltd. recalls Easy Care First Aid Class A ANSI 25 Person, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets
Hazard: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
February 8, 2023DrugsFDA
GFA Production Xiamen Co. Ltd. recalls Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, P
Hazard: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
February 8, 2023DrugsFDA
GFA Production Xiamen Co. Ltd. recalls Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, P
Hazard: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
February 8, 2023DrugsFDA
GFA Production Xiamen Co. Ltd. recalls Adventure First Aid 1.5, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 0120-02
Hazard: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
February 8, 2023DrugsFDA
GFA Production Xiamen Co. Ltd. recalls Adventure First Aid 1.0, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 0120-02
Hazard: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
February 8, 2023DrugsFDA
GFA Production Xiamen Co. Ltd. recalls Adventure Marine 150, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 1015-0150
Hazard: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
February 8, 2023DrugsFDA
GFA Production Xiamen Co. Ltd. recalls Easy Care first aid Burn Cream (benzalkonium chloride 0.13% and lidocaine hydrochloride 0.5%), 0.9 g (0.03 oz) packets p
Hazard: Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls VORICONAZOLE 10MG/ML (10ML DROPPER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls VITAMIN D3-AQUEOUS- 10,000IU/ML (1ML VIAL) INJECTABLE; VITAMIN D3-PF-ETHYL OLEATE- 50,000IU/ML (1ML VIAL) INJECTABLE, Rx
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls VANCOMYCIN FORTIFIED 10MG/ML (1ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFIED 14MG/ML (3ML DROPTAINER) OPH SOLUTION VA
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls TOBRAMYCIN FORTIFIED 15MG/ML OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/HYDROXYCOBAL 25MG/25MG/25MG/25MG/25MG/20MG/ML (3ML VIAL) INJECTABLE THIAMINE
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls TESTOSTERONE 3% (4GM TUBE) OPHTH OINTME TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/0.5MG/ML (3.5ML VIAL) INJECTABLE TEST
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls TACROLIMUS 0.03% OPH SOLUTION TACROLIMUS 0.1% (1ML DROPTAINER) OPH SOLUTION TACROLIMUS -CORN OIL- 0.03% OPH SOLUTION T
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls SEMAGLUTIDE 0.5MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 1MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 2MG/ML (0.5ML VIAL)
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls SCOPOLAMINE HYDROBROMIDE 0.25% OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls PROSTAGLANDIN (PE1) 45MCG (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 17MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 20MCG/M
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls PROGESTERONE-GS OIL- 100MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls POLYHEXAMETHYLENE BIGUANIDE 0.2MG/ML (0.2%) (10ML DROPTAINER) OPTH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls POLIDOCANOL 50MG/ML (5%) (30ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
February 1, 2023DrugsFDA
Pharmacy Innovations recalls PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID (10ML VIAL) 50MG/50MG/ML (5%/5%) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W
Hazard: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.