Drug and pharmaceutical recalls
17623 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2023-02-08FDA-DrugFrenda CorporationClass IIEasy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol, 32 FL. OZ. (946 mL.), Manufactured by: Frenda Corporation Trujilio Alto, PR 00976, UPC 8 91857 00052 3
cGMP Deviations
- 2023-02-08FDA-DrugFrenda CorporationClass IIEasy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (128 Fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00050 9
cGMP Deviations
- 2023-02-08FDA-DrugGFA Production Xiamen Co. Ltd.Class IEasy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2131
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
- 2023-02-08FDA-DrugGFA Production Xiamen Co. Ltd.Class ICVS First Aid Home, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 2980-0700
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
- 2023-02-08FDA-DrugGFA Production Xiamen Co. Ltd.Class IEasy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2132
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
- 2023-02-08FDA-DrugGFA Production Xiamen Co. Ltd.Class IEasy Care First Aid Class A ANSI 25 Person, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2150
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
- 2023-02-08FDA-DrugGFA Production Xiamen Co. Ltd.Class IEasy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2128
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
- 2023-02-08FDA-DrugGFA Production Xiamen Co. Ltd.Class IEasy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 9999-2129
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
- 2023-02-08FDA-DrugGFA Production Xiamen Co. Ltd.Class IAdventure First Aid 1.5, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 0120-0212
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
- 2023-02-08FDA-DrugGFA Production Xiamen Co. Ltd.Class IAdventure First Aid 1.0, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 0120-0213
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
- 2023-02-08FDA-DrugGFA Production Xiamen Co. Ltd.Class IAdventure Marine 150, First Aid Kit, containing Easy Care first aid After Burn Cream 0.9 g packets, Product # 1015-0150
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
- 2023-02-08FDA-DrugGFA Production Xiamen Co. Ltd.Class IEasy Care first aid Burn Cream (benzalkonium chloride 0.13% and lidocaine hydrochloride 0.5%), 0.9 g (0.03 oz) packets packaged in boxes of 10, Treatment for Burns, Made in China for Adventure Ready Brands, 944 Industrial Park Rd., Littleton, NH 03561, NDC 90107-0210, Product # 9999-1515
Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIVORICONAZOLE 10MG/ML (10ML DROPPER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIVITAMIN D3-AQUEOUS- 10,000IU/ML (1ML VIAL) INJECTABLE; VITAMIN D3-PF-ETHYL OLEATE- 50,000IU/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIVANCOMYCIN FORTIFIED 10MG/ML (1ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFIED 14MG/ML (3ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFIED-STS- 50MG/ML OPH SOLUTION VANCOMYCIN-STS- 25MG/ML (2ML DROPTAINER) OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IITOBRAMYCIN FORTIFIED 15MG/ML OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IITHIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/HYDROXYCOBAL 25MG/25MG/25MG/25MG/25MG/20MG/ML (3ML VIAL) INJECTABLE THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/METHYLFOLATE/METHYLCOBAL 10MG/2.5MG/25MG/5MG/5MG/10MG/10MG/ML (1ML VIAL) INJECTABLE THIAMINE/RIBOFLAVIN/NIACINAMIDE/DEXPANTHENOL/PYRIDOXINE 50MG/1MG/100MG/3MG/2MG/ML (30ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IITESTOSTERONE 3% (4GM TUBE) OPHTH OINTME TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/0.5MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/1MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/1MG/ML (3ML VIAL) INJECTABLE TESTOSTERONE CYP/ANASTROZOLE-GS OIL- 200MG/1MG/ML (4ML VIAL) INJECTABLE TESTOSTERONE CYP/ESTRADIOL CYP-SS OIL- 50MG/2MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP/ESTRADIOL CYP-SS OIL- 50MG/2MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE CYP/E
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IITACROLIMUS 0.03% OPH SOLUTION TACROLIMUS 0.1% (1ML DROPTAINER) OPH SOLUTION TACROLIMUS -CORN OIL- 0.03% OPH SOLUTION TACROLIMUS-VET- 0.02% (10ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.02% (15ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.02% (5ML DROPPER) OPHTHALMIC TACROLIMUS-VET- 0.03% (10ML DROPPER) OPHTHALMIC, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IISEMAGLUTIDE 0.5MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 1MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 2MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 4MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 5.4MG/ML (0.5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IISCOPOLAMINE HYDROBROMIDE 0.25% OPH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIPROSTAGLANDIN (PE1) 45MCG (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 17MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 20MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 22.5MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 23MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 30MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 40MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 44.5MCG/ML (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 45MCG/ML (3ML VIAL) INJECTABLE PROSTAGLANDIN E1 50MCG/ML (1ML VIAL) INJECTION PROSTAGLANDIN E1
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIPROGESTERONE-GS OIL- 100MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIPOLYHEXAMETHYLENE BIGUANIDE 0.2MG/ML (0.2%) (10ML DROPTAINER) OPTH SOLUTION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIPOLIDOCANOL 50MG/ML (5%) (30ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIPHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID (10ML VIAL) 50MG/50MG/ML (5%/5%) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIPHENOL 10% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIPE1/PAPAV/PHEN 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 30MCG/30MCG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 5.88MCG/17.65MG/0.588MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT (1ML) 10MCG/30MG/2MG/ML INJECTABLE PE1/PAPAV/PHENT 10MCG/18MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 10MCG/30MG/0.5MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 10MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 10MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 11.8MCG/18MG/0.6MG/ML (1ML VIAL)
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIPE1/PAPAV/ATROP/CHLOPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 100MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 15MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM 30MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/ATROP/CHLORPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
- 2023-02-01FDA-DrugPharmacy InnovationsClass IIPAPAVERINE/PHENTOLAMINE 30MG/0.5MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/1MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/2MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/3MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENTOLAMINE 30MG/5MG/ML (1ML VIAL) INJECTABLE; Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
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