Drug Recall Enforcement Reports
What are the Drug Enforcement Reports?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.
The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0309-2023 | 12-27-2022 | MYCAMINE 100MG IN NS 100ML, antifungal, Rx Only, use with a homepump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 5 bags | Class II | Terminated |
| D-0286-2023 | 12-27-2022 | DAPTOMYCIN (a)360MG in NS 18ML syringe (b)580MG IN NS 29ML syringe(c) 630MG IN NS 31.5ML used with a home pump; antibiotic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320 | Lack of sterility assurance | Sentara Infusion Services / 17 bags | Class II | Terminated |
| D-0245-2023 | 12-23-2022 | Adventure 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. | GFA Production Xiamen Co. Ltd. / 2016 packets | Class I | Terminated |
| D-0248-2023 | 12-23-2022 | Easy 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. | GFA Production Xiamen Co. Ltd. / 37464 packets | Class I | Terminated |
| D-0249-2023 | 12-23-2022 | Easy 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. | GFA Production Xiamen Co. Ltd. / 194460 packets | Class I | Terminated |
| D-0252-2023 | 12-23-2022 | CVS 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. | GFA Production Xiamen Co. Ltd. / 15000 packets | Class I | Terminated |
| D-0247-2023 | 12-23-2022 | Adventure 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. | GFA Production Xiamen Co. Ltd. / 75381 packets | Class I | Terminated |
| D-0253-2023 | 12-23-2022 | Easy 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. | GFA Production Xiamen Co. Ltd. / 7200 packets | Class I | Terminated |
| D-0244-2023 | 12-23-2022 | Easy 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. | GFA Production Xiamen Co. Ltd. / 2880 packets | Class I | Terminated |
| D-0251-2023 | 12-23-2022 | Easy 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. | GFA Production Xiamen Co. Ltd. / 8280 packets | Class I | Terminated |
| D-0250-2023 | 12-23-2022 | Easy 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. | GFA Production Xiamen Co. Ltd. / 66400 packets | Class I | Terminated |
| D-0246-2023 | 12-23-2022 | Adventure 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. | GFA Production Xiamen Co. Ltd. / 60048 packets | Class I | Terminated |
| D-0192-2023 | 12-22-2022 | Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0222-2023 | 12-22-2022 | METHYLCOBALAMIN 12.5MG/ML (1ML VIAL) INJECTABLE METHYLCOBALAMIN 25MG/ML (1.2ML VIAL) INJECTABLE; METHYLCOBALAMIN 3MG/ML (1ML VIAL) INJECTABLE; METHYLCOBALAMIN 5MG/ML (0.2ML VIAL) INJECTABLE; METHYLCOBALAMIN 5MG/ML (1ML VIAL) INJECTABLE; METHYLCOBALAMIN-PF- 12.5MG/ML (1ML VIAL) INJECTABLE; METHYLCOBALAMIN-PF- 25MG/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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0241-2023 | 12-22-2022 | VANCOMYCIN 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0226-2023 | 12-22-2022 | PAPAVERINE/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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0190-2023 | 12-22-2022 | 5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0206-2023 | 12-22-2022 | ESTRADIOL CYP/TEST CYP- SS OIL- 2MG/50MG/ML (1.5ML VIAL) INJECTABLE; ESTRADIOL CYP/TEST CYP -SS OIL- 2MG/25MG/ML (1ML VIAL) INJECTABLE; ESTRADIOL CYP-CS OIL- 5MG/ML (1.25ML VIAL) INJECTABLE; ESTRADIOL CYP-GS OIL- 5MG/ML (1ML VIAL) INJECTABLE ESTRADIOL CYP-SS OIL- 5MG/ML (1.5ML VIAL) INJECTABLE; ESTRADIOL CYP-SS OIL- 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0229-2023 | 12-22-2022 | PHENOL 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0194-2023 | 12-22-2022 | Atropine sulfate 0.05%, 1ML dropper, and Atropine sulfate 0.01%, 1 ML dropper, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0232-2023 | 12-22-2022 | POLYHEXAMETHYLENE 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0225-2023 | 12-22-2022 | NADH 10MG/ML (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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0207-2023 | 12-22-2022 | Ethyl Alcohol 95% (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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0201-2023 | 12-22-2022 | DEXAMETHASONE 16MG/ML (3ML VIAL) INJECTABLE; DEXAMETHASONE 24MG/ML INJECTABLE; DEXAMETHASONE-PF- 0.1% (1ML 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0230-2023 | 12-22-2022 | PHOSPHATIDYLCHOLINE/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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0237-2023 | 12-22-2022 | TACROLIMUS 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0203-2023 | 12-22-2022 | Edetate Calcium Disodium 400MG/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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0212-2023 | 12-22-2022 | GLYCERIN STERILE 99% 2ML VIAL and 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0242-2023 | 12-22-2022 | VITAMIN 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0187-2023 | 12-22-2022 | Hydroxocobalamin 25MG/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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0218-2023 | 12-22-2022 | LIDOCAINE-PF- 5% (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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0214-2023 | 12-22-2022 | HEPARIN/LIDO HCL/SODIUM BICARB 100U/2MG/16.8MG/ML (20ML SYRINGE) IRRIGATION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0188-2023 | 12-22-2022 | Methylcobalamin 1MG/ML (1ML vial); Methylcobalamin 3MG/ML (1ML vial); Methylcobalamin 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0208-2023 | 12-22-2022 | FLURBIPROFEN -CORN OIL- 0.04% (3ML 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0200-2023 | 12-22-2022 | Cyclosporine (A) 0.1%; Cyclosporine (A) 0.2%; Cyclosporine (A) 1%; Cyclosporine (A) 2%; Cyclosporine (A) - Corn oil - 1% 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0217-2023 | 12-22-2022 | LEVEMIR-STS- 100U/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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0235-2023 | 12-22-2022 | SCOPOLAMINE 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0239-2023 | 12-22-2022 | THIAMINE/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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0091-2023 | 12-22-2022 | Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15 Package NDCs: 50268-363-11; 50268-363-15 | Failed impurities/degradation specifications: Out of specification for unknown impurities. | AVKARE LLC / 1237 cartons | Class II | Completed |
| D-0184-2023 | 12-22-2022 | Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045. NDC Vial 0409-3515-11; NDC Carton 0409-3515-01 Package NDCs: 0409-6531-12; 0409-6531-02; 0409-6533-11; 0409-6533-01; 0409-6533-21; 0409-4332-11; 0409-4332-01; 0409-3515-11; 0409-3515-01 | Presence of Particulate Matter: Glass particulate matter detected in injectable. | Pfizer Inc. / 89,700 vials | Class I | Terminated |
| D-0186-2023 | 12-22-2022 | Chlorpheniramine/Hyoscyamine (1ML) 10MG/0.25MG/ML Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0234-2023 | 12-22-2022 | PROSTAGLANDIN (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 60MCG/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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0227-2023 | 12-22-2022 | PE1/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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0238-2023 | 12-22-2022 | TESTOSTERONE 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/ESTRADIOL CYP-SS OIL- 50MG/2MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP/PROP(80/20)-GS OIL- 200MG/ML (5ML VIAL) INJECTABLE TESTOSTERONE CYP-CS OIL-PF- 80MG/ML (0.7ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 100MG/ML (1.2ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 150MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 150MG/ML (4ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 200MG/ML (2.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 200MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 200MG/ML (3ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 200MG/ML (4ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 20MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 20MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 25MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 25MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 25MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 300MG/ML (5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 50MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 50MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 50MG/ML (2.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 50MG/ML (3.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 75MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 75MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 80MG/ML (1.5ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL- 80MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE CYP-GS OIL-PF- 75MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE CYP-OLIVE OIL- 50MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-SS OIL- 125MG/ML (5ML VIAL) INJECTABLE TESTOSTERONE CYP-SS OIL- 200MG/ML (5ML VIAL) INJECTABLE TESTOSTERONE CYP-SS OIL- 50MG/ML (2ML VIAL) INJECTABLE TESTOSTERONE CYP-SS OIL-PF- 80MG/ML (1ML VIAL) INJECTABLE TESTOSTERONE ENAN-GS OIL-PF- 300MG/ML (0.4ML VIAL) INJECTABLE TESTOSTERONE-PF- 50MG/ML (5%) (1ML DROPTAINERS) OPHTHALMIC, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0199-2023 | 12-22-2022 | Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML (30ML syringe) Irrigation, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0209-2023 | 12-22-2022 | GENTAMICIN BLADDER 0.08MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (30ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.48MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.64MG/ML (25ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.64MG/ML (25ML SYRINGE) IRRIGATION, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0191-2023 | 12-22-2022 | Acetylcysteine 10% Ophthalmic Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0219-2023 | 12-22-2022 | MAGNESIUM CHLORIDE HEXAHYDRATE-PF- 200MG/ML (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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0240-2023 | 12-22-2022 | TOBRAMYCIN 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0197-2023 | 12-22-2022 | Ceftazidime Intravitreal (1ML vial) 22.5 MG/ML(2.25MG/0.1ML) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0228-2023 | 12-22-2022 | PE1/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) INJECTABLE PE1/PAPAV/PHENT 12.2MCG/19.29MG/1.22MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 12.5MCG/24MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 20MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 20MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 30MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 30MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 30MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 40MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.88MCG/17.65MG/0.588MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.88MCG/18MG/0.6MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.8MCG/17.44MG/0.64MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5.9MCG/17.64MG/0.59MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 50MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 50MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5MCG/15MG/0.5MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 5MCG/30MG/1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 60MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 60MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 70MCG/30MG/3MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 8.3MCG/25MG/0.83MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT 80MCG/30MG/3MG (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 10MCG/12MG/1MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 10MCG/30MG/2MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 20MCG/30MG/2MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 20MCG/30MG/4MG/0.4MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 30MCG/30MG/1MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 30MCG/30MG/2MG/0.15MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 40MCG/30MG/4MG/0.4MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 50MCG/30MG/2MG/0.1MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHENT/ATROP 60MCG/30MG/4MG/0.15MG/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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0243-2023 | 12-22-2022 | VORICONAZOLE 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0189-2023 | 12-22-2022 | Minoxidil 0.75% (1.5ML 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0210-2023 | 12-22-2022 | GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 200MG/ML (1ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 220MG/ML (30ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (1ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (2ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED-PF- 200MG/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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0220-2023 | 12-22-2022 | METHION/INOSIT/CHOLINE/CYANOCOBAL 25MG/50MG/50MG/1MG/ML (1ML VIAL) INJECTABLE; METHION/INOSIT/CHOLINE/METHYLCOBAL 15MG/50MG/100MG/1MG/ML (1ML VIAL) INJECTABLE; METHION/INOSIT/CHOLINE/RIBOFLA/NIACINAMIDE/PYRIDOX/ASCORBIC ACID 15.625MG/31.25MG/31.25MG/6.25MG/62.5MG/6.25MG/62.5MG/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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0196-2023 | 12-22-2022 | Buprenorphine HCL 0.9 MG/ML (25ML 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0204-2023 | 12-22-2022 | EDETATE DISODIUM (VET) 1% (3ML 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0211-2023 | 12-22-2022 | GLYCERIN 72% (W/V) (15ML 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0205-2023 | 12-22-2022 | Estradiol 0.05% 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0223-2023 | 12-22-2022 | MITOMYCIN 0.2MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.2MG/ML (1ML VIAL) 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0221-2023 | 12-22-2022 | METHOTREXATE INTRAVITREAL (1ML VIAL) 4MG/ML (400MCG/0.1ML) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0213-2023 | 12-22-2022 | GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 31%(V/V)/0.17%/0.00017% (10ML VIALS); GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 48.7%(W/V)/0.67%/0.00067% (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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0224-2023 | 12-22-2022 | MITOMYCIN 0.4MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.4MG/ML (1ML VIAL) OPH SOLUTION; MITOMYCIN 0.4MG/ML (4ML VIAL) 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0185-2023 | 12-22-2022 | Dutasteride 0.1% (1.5ML 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0193-2023 | 12-22-2022 | Apomorphine HCL 2MG/ML (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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0198-2023 | 12-22-2022 | Cholecalciferol (Vitamin D3) 100,000U/ML Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0236-2023 | 12-22-2022 | SEMAGLUTIDE 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0195-2023 | 12-22-2022 | BSS Plus/Lidocaine Opth 1% (1ML syringe) Injectable, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA. | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0215-2023 | 12-22-2022 | HYDROXOCOBALAMIN-PF- 1MG/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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0231-2023 | 12-22-2022 | POLIDOCANOL 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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0130-2023 | 12-22-2022 | Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular Injection, 1 ml, Single Dose Vial, Compounded by Pine Pharmaceuticals, 355 Riverwalk Pkwy, Tonawanda, NY 14150. NDC 69194-0948-1 | CGMP Deviations: Raw material recalled by repackager, due to discoloration. | Pine Pharmaceuticals, LLC / 11,453 vials | Class II | Terminated |
| D-0233-2023 | 12-22-2022 | PROGESTERONE-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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0202-2023 | 12-22-2022 | Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF- 250MG/100MG/1MG/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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0216-2023 | 12-22-2022 | KETAMINE 50MG/ML (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. | Pharmacy Innovations / N/A | Class II | Terminated |
| D-0093-2023 | 12-21-2022 | Timolol Maleate Ophthalmic Solution, USP 0.5%, 2.5 mL, Rx Only, Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Mfg for: Apotex Corp. Weston, FL 33326, NDC 60505-1005-4 | Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life. | Apotex Corp. / 22,027 bottles | Class III | Terminated |
| D-0165-2023 | 12-20-2022 | Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-586-01 (Individual Dose NDC: 60687-586-11) | Failed Impurities/Degradations Specifications | Amerisource Health Services LLC / 3,091 cartons | Class II | Terminated |
| D-0098-2023 | 12-20-2022 | Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-0659-07, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, Repackaged NDC 70518-2404-00. | Failed Impurities/Degradation specifications | RemedyRepack Inc. / 132 Cards of 30 = 3960 Tablets | Class II | Terminated |
| D-0179-2023 | 12-19-2022 | Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx only, Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901. Product Code EP130 | Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product | Spectrum Laboratory Products, Inc. / 1 bottle | Class I | Terminated |
| D-0180-2023 | 12-19-2022 | Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G; (b)1 G, (c) 25 G, (d) 5 G; Rx only. Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901. | Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product | Spectrum Laboratory Products, Inc. / 7 x 100G; 17 x 1G; 6 x 25G; 20 x 5G | Class I | Terminated |
| D-0090-2023 | 12-16-2022 | Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton, Rx Only, Mfd. by: THYMOORGAN PHARMAZIE GmbH, Germany, Distributed by Hikma Berkeley Heights, NJ 07922, NDC 0143-9299-01 Package NDCs: 0143-9299-01; 0143-9299-10 | Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-count carton of Ganciclovir 500 mg. | Hikma Pharmaceuticals USA Inc. / 13,760 vials | Class II | Terminated |
| D-0087-2023 | 12-16-2022 | Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, NDC 13107-014-01 Package NDCs: 13107-014-01; 13107-015-01 | Failed Impurities/Degradation Specifications | Aurolife Pharma, LLC / 7344 bottles | Class II | Ongoing |
| D-0257-2023 | 12-15-2022 | 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 8 91857 00047 9, Manufactured by: Frenda Corporation Trujillo Alto, PR 00976 | cGMP Deviations | Frenda Corporation / 65,376 bottles | Class II | Terminated |
| D-0260-2023 | 12-15-2022 | Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 mL) UPC 8 70373 01323 1; b) 16 FL OZ (473 mL) UPC 8 70373 01332 3; c) 1 Gallon (128 FL OZ) 3785.41 mL UPC 8 70373 01330 4, Dist. By Target Price, Inc. Catano, PR | cGMP Deviations | Frenda Corporation / 12,130 bottles | Class II | Terminated |
| D-0258-2023 | 12-15-2022 | 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 91857 00055 4; c) Rubbing Alcohol 10 fl. oz. (296 mL) UPC 8 91857 00044 8, Manufactured by Frenda Corporation Trujillo Alto, PR 00976 | cGMP Deviations | Frenda Corporation / 44,140 bottles | Class II | Terminated |
| D-0255-2023 | 12-15-2022 | Easy 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 | Frenda Corporation / 8475 bottles | Class II | Terminated |
| D-0254-2023 | 12-15-2022 | Easy 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 | Frenda Corporation / 144 bottles | Class II | Terminated |
| D-0256-2023 | 12-15-2022 | Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Frenda Corporation Trujillo Alto, PR 00976, UPC 8 91857 00054 7 | cGMP Deviations | Frenda Corporation / 164 bottles | Class II | Terminated |
| D-0259-2023 | 12-15-2022 | Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gallon (128 FL OZ) 3785.41 mL, Dist. by Target Price, Inc. Catano, PR, UPC 8 70373 01326 2 | cGMP Deviations | Frenda Corporation / 124 bottles | Class II | Terminated |
| D-0081-2023 | 12-12-2022 | Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged in 0.22 Fl. oz. (6.6 mL) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01. | cGMP Deviations | Atlantic Management Resources Ltd. / 461 bottles | Class II | Terminated |
| D-0084-2023 | 12-12-2022 | Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-711-01. | cGMP Deviations | Atlantic Management Resources Ltd. / 26 bottles | Class II | Terminated |
| D-0082-2023 | 12-12-2022 | Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g) bottles, Mfg. for/Dist. By Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233712-01. | cGMP Deviations | Atlantic Management Resources Ltd. / 51 bottles | Class II | Terminated |
| D-0083-2023 | 12-12-2022 | ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g) bottles, Dist. by: Endometriosis Assoc. Inc. (International), Mfg. by Claire Ellen Topicals, P.O. Box 901 Westborough, MA 01581, USA, NDC# 66233-712-01. | cGMP Deviations | Atlantic Management Resources Ltd. / 72 bottles | Class II | Terminated |
| D-0100-2023 | 12-12-2022 | Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India. NDC 68180-659-06 Package NDCs: 68180-658-06; 68180-658-01; 68180-659-06; 68180-659-07; 68180-659-01 | Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study. | Lupin Pharmaceuticals Inc. / 16,056 30 count bottles | Class II | Terminated |
| D-0092-2023 | 12-09-2022 | Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution, packaged as a a) 2.5 gallon bottle (9,464 ml), NDC 55533-524-02, and b) 55 gallon bottle (208,198 ml), NDC 55533-524-03, Manufactured for: Multi-Mist Products A Division of NCH Corporation 1618 Northgate, Irving, Texas 75062 | CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess of allowed limits. | NCH Life Sciences LLC / 10,930 gallons | Class II | Completed |
| D-0267-2023 | 12-08-2022 | Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 30 mL Sterile Multiple Use Vial, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc, Santa Ana, CA 92704. | Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy. | McGuff Compounding Pharmacy Services, Inc. / 255 vials | Class II | Terminated |
| D-0266-2023 | 12-08-2022 | Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 2 mL Sterile Single Use Vial, Preservative-Free, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc, Santa Ana, CA 92704. | Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy. | McGuff Compounding Pharmacy Services, Inc. / 11 vials | Class II | Terminated |
| D-0089-2023 | 12-07-2022 | Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09 Package NDCs: 68180-556-09; 68180-557-09; 68180-557-03; 68180-558-09; 68180-558-03; 68180-554-09; 68180-554-03; 68180-559-03; 68180-559-09 | CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. | Lupin Pharmaceuticals Inc. / 23,736 | Class II | Terminated |
| D-0088-2023 | 12-07-2022 | Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09 Package NDCs: 68180-556-09; 68180-557-09; 68180-557-03; 68180-558-09; 68180-558-03; 68180-554-09; 68180-554-03; 68180-559-03; 68180-559-09 | CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. | Lupin Pharmaceuticals Inc. / 30,612 bottles | Class II | Terminated |
| D-0182-2023 | 12-06-2022 | Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Distributed by: Pfizer, Madison, NJ 07940, UPC 3 0573 0169 49 3 | Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back | Glaxosmithkline Consumer Healthcare Holdings DBA Haleon / 88,380 capsules | Class I | Terminated |
| D-0183-2023 | 12-06-2022 | Advil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Pfizer, Madison, NJ 07940, UPC 3 0573 1769 13 5 | Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back | Glaxosmithkline Consumer Healthcare Holdings DBA Haleon / 209,292 capsules | Class I | Terminated |
