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 August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0397-2022 | 12-06-2021 | Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 mg/mL), 0.5mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-0733-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 168 syringes | Class II | Terminated |
| D-0398-2022 | 12-06-2021 | Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446 NDC 05446-1003-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 1720 syringes | Class II | Terminated |
| D-0406-2022 | 12-06-2021 | Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1505-05 | Lack of Assurance of Sterility | Edge Pharma, LLC / 457 syringes | Class II | Terminated |
| D-0409-2022 | 12-06-2021 | Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.2 mg/mL), 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1011-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 154 syringes | Class II | Terminated |
| D-0435-2022 | 12-06-2021 | Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per vial, Edge Parma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1156-03 | CGMP Deviations | Edge Pharma, LLC / 20 vials | Class II | Terminated |
| D-0400-2022 | 12-06-2021 | Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1427-10 | Lack of Assurance of Sterility. | Edge Pharma, LLC / 80 droppers | Class II | Terminated |
| D-0410-2022 | 12-06-2021 | Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0.8mg/0.8 mL (1mg/mL), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LL, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1050-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 860 syringes | Class II | Terminated |
| D-0446-2022 | 12-06-2021 | Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Single Dose Syreinge for Topical Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1341-01 | CGMP Deviations | Edge Pharma, LLC / 7788 syringes | Class II | Terminated |
| D-0404-2022 | 12-06-2021 | Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile Ophthalmic Solution for Injection (PF), 2%/0.375%, 8 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1548-18 | Lack of Assurance of Sterility | Edge Pharma, LLC / 1202 syringes | Class II | Terminated |
| D-0396-2022 | 12-06-2021 | Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, (802) 992-1178, NDC 05446-1268-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 8140 syringes | Class II | Terminated |
| D-0437-2022 | 12-06-2021 | LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Single Dose Syringe for Topical Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT, NDC 05446-0607-01 | CGMP Deviations | Edge Pharma, LLC / 26917 syringes | Class II | Terminated |
| D-0402-2022 | 12-06-2021 | Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preservative Free, 0.025%/0.75%, 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0863-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 2568 syringes | Class II | Terminated |
| D-0394-2022 | 12-06-2021 | ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-0637-03 | Lack of Assurance of Sterility | Edge Pharma, LLC / 30 bags | Class II | Terminated |
| D-0438-2022 | 12-06-2021 | Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1256-01, packaged in bottles. no label | CGMP Deviations | Edge Pharma, LLC / 386 bottles | Class II | Terminated |
| D-0417-2022 | 12-06-2021 | Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syringe for IV Injection, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1652-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 5335 syringes | Class II | Terminated |
| D-0401-2022 | 12-06-2021 | Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1428-10 | Lack of Assurance of Sterility | Edge Pharma, LLC / | Class II | Terminated |
| D-0439-2022 | 12-06-2021 | Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallow, 30 grams per jar, Multiple Dose Container For Topical Oral Use,Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0790-10 | CGMP Deviations | Edge Pharma, LLC / 353 jars | Class II | Terminated |
| D-0408-2022 | 12-06-2021 | Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.4mg/mL) 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1009-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 163 syringes | Class II | Terminated |
| D-0428-2022 | 12-06-2021 | BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1235-01 | CGMP Deviations | Edge Pharma, LLC / 1173 jars | Class II | Terminated |
| D-0445-2022 | 12-06-2021 | Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single Dose Syringe for Oral Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1132-03 | CGMP Deviations | Edge Pharma, LLC / 757 syringes | Class II | Terminated |
| D-0442-2022 | 12-06-2021 | Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%, Spear-Peppermint, Multiple Dose Container for Topical Oral Use, 30 grams per jar, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0408-10 | CGMP Deviations | Edge Pharma, LLC / 175 jars | Class II | Terminated |
| D-0441-2022 | 12-06-2021 | Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-Marshmallow, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-1018-10 | CGMP Deviations | Edge Pharma, LLC / 418 jars | Class II | Terminated |
| D-0426-2022 | 12-06-2021 | Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1458-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 1825 bags | Class II | Terminated |
| D-0433-2022 | 12-06-2021 | Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0622-01 | CGMP Deviations | Edge Pharma, LLC / 56 cartons | Class II | Terminated |
| D-0421-2022 | 12-06-2021 | Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/Ketorolac Sterile Ophthalmic Solution, 2.5%/0.25%/0.25%/0.125%, 0.5 mL syringe, Single Use Syringe, For Topical Ophthalmic Use, NDC 05446-0993-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 2562 syringes | Class II | Terminated |
| D-0429-2022 | 12-06-2021 | Cantharidin Gel-Forming Suspension, 0.7%, 10 mL per vial, Multiple Dose Vial for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05546 NDC 05446-0572-03 | CGMP Deviations | Edge Pharma, LLC / 1173 vials | Class II | Terminated |
| D-0418-2022 | 12-06-2021 | PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preservative Free), Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT NDC 05446-1667-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 3930 bags | Class II | Terminated |
| D-0395-2022 | 12-06-2021 | Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and Nerve Block, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0850-10 | Lack of Assurance of Sterility | Edge Pharma, LLC / 4465 syringes | Class II | Terminated |
| D-0447-2022 | 12-06-2021 | Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1195-03, packaged in bottles. | CGMP Deviations | Edge Pharma, LLC / 114 bottles | Class II | Terminated |
| D-0411-2022 | 12-06-2021 | Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use Syringe for IV or IM Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1549-05 | Lack of Assurance of Sterility | Edge Pharma, LLC / 160 syringes | Class II | Terminated |
| D-0419-2022 | 12-06-2021 | Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preservative Free, 1.5%/1%, 0.8mL per syringe, Single Use Syringe For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1118-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 2750 syringes | Class II | Terminated |
| D-0432-2022 | 12-06-2021 | CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocortisone/Amphotericin B Otic Powder, 50mg/ 30mg/ 25mg/ 5mg, 5 count bottle, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1634-01 | CGMP Deviations | Edge Pharma, LLC / 440 cartons | Class II | Terminated |
| D-0448-2022 | 12-06-2021 | Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe for Oral Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01 | CGMP Deviations | Edge Pharma, LLC / 6925 syringes | Class II | Terminated |
| D-0412-2022 | 12-06-2021 | MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.13mL (25 mg/mL) 0.13 mL per syringe, Dose: 1.25mg/0.05mL, Single Use Syringe For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-1661-13 | Lack of Assurance of Sterility | Edge Pharma, LLC / 199 syringes | Class II | Terminated |
| D-0423-2022 | 12-06-2021 | Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5% 0.5mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-1680-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 1773 syringes | Class II | Terminated |
| D-0430-2022 | 12-06-2021 | Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL per vial, Multiple Dose Vials for Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0970-03 | CGMP Deviations | Edge Pharma, LLC / 2204 vials | Class II | Terminated |
| D-0427-2022 | 12-06-2021 | Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446 NDC 05446-1459-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 749 bags | Class II | Terminated |
| D-0403-2022 | 12-06-2021 | Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL), 50 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1566-50 | Lack of Assurance of Sterility | Edge Pharma, LLC / 627 syringes | Class II | Terminated |
| D-0422-2022 | 12-06-2021 | Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmic Solution, 10%/ 0.25%/ 0.25%/0.125%, 10 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-0859-03 | Lack of Assurance of Sterility | Edge Pharma, LLC / 40 droptainers | Class II | Terminated |
| D-0405-2022 | 12-06-2021 | Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preservative Free, 3 mL per syringe,(NDC 05446-1600-05), Kit includes; individual syringe: Methacholine Chloride,16 mg/mL (contains 48 mg) NDC 05446-1241-01; Methacholine Chloride 4 mg/mL (contains 12mg), NDC 05446-1246-01; Methacholine chloride 1mg/mL (contains 3 mg), NDC 05446-1247-01; Methacholine chloride 0.25mg/mL (contains 0.75mg), NDC 05446-1248-01; and Methacholine chloride 0.0625mg/mL NDC 05446-1249-01 Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446 | Lack of Assurance of Sterility | Edge Pharma, LLC / 1007 syringes | Class II | Terminated |
| D-0414-2022 | 12-06-2021 | Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic Solution, 10%/1%/0.3%/0.125%, 0.8 mL per syringe, Single Use Syringe, For Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1270-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 2463 vials | Class II | Terminated |
| D-0444-2022 | 12-06-2021 | Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose Container, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1045-03 | CGMP Deviations | Edge Pharma, LLC / 231 bottles | Class II | Terminated |
| D-0436-2022 | 12-06-2021 | LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Use, Edge Pharma, LLC, 856 Hercules, VT, Colchester, VT 05446, NDC 05446-1647-01 | CGMP Deviations | Edge Pharma, LLC / 74 jars | Class II | Terminated |
| D-0420-2022 | 12-06-2021 | Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per dropper, Multiple Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Colchester, VT 05446, NDC 05446-0815-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 363 droptainers | Class II | Terminated |
| D-0415-2022 | 12-06-2021 | Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1545-05 | Lack of Assurance of Sterility | Edge Pharma, LLC / 3747 syringes | Class II | Terminated |
| D-0434-2022 | 12-06-2021 | Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per vial, Edge Pharma, LLC, 856 Hercules Dr, Colchester VT, 05446, NDC 05446-1047-03 | CGMP Deviations | Edge Pharma, LLC / 63 vials | Class II | Terminated |
| D-0458-2022 | 12-03-2021 | CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321. | Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. | Dental Alliance Holdings LLC / 8 single tubes of lot 492106 and 50 single tubes of lot 492107 | Class III | Terminated |
| D-0283-2022 | 12-03-2021 | Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409 | Lack of Processing Controls | Valgene Incorporated dba Cape Drugs / 27 vials | Class II | Terminated |
| D-0284-2022 | 12-03-2021 | B-Complex, injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Road Annapolis, MD 21409 | Lack of Processing Controls | Valgene Incorporated dba Cape Drugs / 12 vials | Class II | Terminated |
| D-0457-2022 | 12-03-2021 | CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and six boxes of 4fl.oz. Carifree CTx4 Treatment Rinse. | Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. | Dental Alliance Holdings LLC / 90 single tubes of 352110 and 315 single tubes of 352111 | Class III | Terminated |
| D-0459-2022 | 12-03-2021 | CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321. | Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. | Dental Alliance Holdings LLC / 360 individual tubes of lot 142017. | Class III | Terminated |
| D-0456-2022 | 12-03-2021 | CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and two bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle an two boxes of 4fl.oz. Carifree CTx4 Treatment Rinse. | Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. | Dental Alliance Holdings LLC / 225 single tube of lot 31217 and 99 single tube of 312108 | Class III | Terminated |
| D-0455-2022 | 12-03-2021 | CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle. | Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. | Dental Alliance Holdings LLC / 180 single tube of lot 272109 and 180 single tube count of lot 272110 | Class III | Terminated |
| D-0453-2022 | 12-03-2021 | CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 Distributed in 12-pk/cases | Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. | Dental Alliance Holdings LLC / 6612 individual tubes for the 12 pack and 15 individual tubes for the 2 oz. of Lot 142017 | Class III | Terminated |
| D-0454-2022 | 12-03-2021 | CTx7 Kit, contains one tube CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and one bottle of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle. | Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. | Dental Alliance Holdings LLC / 3 single tubes of lot 192107 and 3 single tubes of 192108 | Class III | Terminated |
| D-0368-2022 | 12-03-2021 | Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 --- NDC 50383-961-34 | Labeling: Missing Label | Akorn, Inc. / 8184 bottles | Class III | Terminated |
| D-0367-2022 | 12-03-2021 | Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC 50383-965-30 | Labeling: Missing Label | Akorn, Inc. / 10,836 bottles | Class III | Terminated |
| D-0299-2022 | 12-03-2021 | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2 Package NDCs: 61958-2902-2; 61958-2901-2 | Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates. | Gilead Sciences, Inc. / 53,473 vials | Class I | Terminated |
| D-0365-2022 | 12-02-2021 | Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. Bharuch-392130, India Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. Package NDCs: 13668-268-30; 13668-268-01; 13668-268-10; 13668-268-31; 13668-268-05; 13668-271-01; 13668-271-10; 13668-271-49; 13668-271-05 | Failed Dissolution Specifications | Torrent Pharma Inc. / 15,336 Bottles | Class II | Terminated |
| D-0285-2022 | 12-01-2021 | Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-159-30 | Superpotent; Hydrochlorothiazide | Torrent Pharma Inc. / 27,312 Bottles | Class III | Terminated |
| D-0265-2022 | 11-30-2021 | 5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66 Package NDCs: 0409-7100-68; 0409-7100-66; 0409-7100-69; 0409-7100-67; 0409-7100-04; 0409-7100-02 | Lack of sterility assurance: bag has the potential to leak. | Pfizer Inc. / 765 bags | Class II | Terminated |
| D-0296-2022 | 11-30-2021 | Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64 Package NDCs: 63739-997-64 | Superpotent Drug: Minimally superpotent | Teligent Pharma, Inc. / 7,176 bottles | Class II | Ongoing |
| D-0295-2022 | 11-30-2021 | Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64 Package NDCs: 63739-997-64 | Superpotent Drug | Teligent Pharma, Inc. / 6,816 bottles | Class I | Ongoing |
| D-0298-2022 | 11-30-2021 | Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methanol, in 55-gallon drums, Aroma Release Technology, Inc., 7026 Discovery Drive, Chattanooga, TN 37416 | Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol | Aroma Release Technologies Inc / 37 55-gallon drums | Class I | Terminated |
| D-0278-2022 | 11-29-2021 | Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx only, Mfg: SOLA Pharmaceuticals Preferred Pharmaceuticals, Inc., NDC 68788-7707-01 | Defective container: Out of specification for container integrity leading to bottles leaking. | Preferred Pharmaceuticals, Inc. / 72 bottles | Class II | Ongoing |
| D-0288-2022 | 11-29-2021 | Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42 | Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL | Denver Solutions, LLC DBA Leiters Health / 1440 vials | Class II | Terminated |
| D-0327-2022 | 11-29-2021 | PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coated, bulk OTC tablets packaged in corrugated boxes lined with 2 polyethylene bags 100 lb, ULTRAtab Laboratories, Inc. NDC# 62959-560-00, Product Code M560L | CGMP Deviations: failed stability results, inadequate laboratory investigations, | ULTRAtab Laboratories, Inc. / 14 bulk lots (approximately 1,987,951 tablets each) | Class II | Terminated |
| D-0250-2024 | 11-23-2021 | Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deodorant Spray, Topical spray can, Net WT 6.0 OZ (170g), Distributed by Procter & Gamble, Cincinnati, OH 45202. NDC: 37000-199-60, UPC 0 12044 00191 2 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0239-2024 | 11-23-2021 | Old Spice, SWEAT DEFENSE, STRONGER SWAGGER, Dry Spray, 48 Hour, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant, Topical Spray Can, Net WT 3.8 oz (107 g), Distr. by: Procter & Gamble, Cincinnati, OH 45202. NDC 69423-386-10, UPC 0 37000 73034 7 OR UPC 0 12044 04475 9 (12 Pack, older label) | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0247-2024 | 11-23-2021 | Secret, OUTLAST, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Completely Clean, Topical spray can 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-384-10, UPC 0 37000 74764 2 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0244-2024 | 11-23-2021 | Secret, Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Lavender, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-383-10, UPC: 0 37000 72986 0 | Chemical contamination: presence of benzene | The Procter & Gamble Company / unknown | Class I | Terminated |
| D-0246-2024 | 11-23-2021 | Secret, Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-380-10, UPC 0 37000 79884 2 | Chemical contamination: presence of benzene | The Procter & Gamble Company / unknown | Class I | Terminated |
| D-0245-2024 | 11-23-2021 | Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Light Essentials, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-382-10, UPC 0 37000 72992 1 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0240-2024 | 11-23-2021 | Old Spice, SWEAT DEFENSE PURE SPORT PLUS, Dry Spray, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant, Topical spray can, Net WT 3.8 oz (107 g) cans, Distr. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-387-10, UPC 0 37000 72974 7 | Chemical contamination: presence of benzene | The Procter & Gamble Company / unknown | Class I | Terminated |
| D-0256-2024 | 11-23-2021 | Secret Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-380-10, UPC 0 37000 79884 2 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0252-2024 | 11-23-2021 | Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Anti-Perspirant, Topical spray can 3.8 OZ (107 g), Distr. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-385-10, UPC 0 37000 74947 9 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0251-2024 | 11-23-2021 | Old Spice, SWEAT DEFENSE PURE SPORT PLUS, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant, Topical spray can, Net WT 3.8 oz (107 g) cans, Distr. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-387-10, UPC 0 37000 72974 7 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0248-2024 | 11-23-2021 | Secret OUTLAST Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Protecting Powder, Topical spray can 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-478-10, UPC 0 37000 74772 7 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0241-2024 | 11-23-2021 | Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Anti-Perspirant, Topical spray can 3.8 OZ (107 g), Distr. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-385-10, UPC 0 37000 74947 9 | Chemical contamination: presence of benzene | The Procter & Gamble Company / unknown | Class I | Terminated |
| D-0243-2024 | 11-23-2021 | Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Waterlily, Topical Spray Can, Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-381-10; UPC 0 37000 72372 1; 12/pack UPC 0 37000 72991 4 | Chemical contamination: presence of benzene | The Procter & Gamble Company / unknown | Class I | Terminated |
| D-0238-2024 | 11-23-2021 | Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deodorant Spray, Topical spray can, Net WT 6.0 OZ (170g), Distributed by Procter & Gamble, Cincinnati, OH 45202. NDC: 37000-199-60, UPC 0 12044 00191 2 | Chemical contamination: presence of benzene | The Procter & Gamble Company / unknown | Class I | Terminated |
| D-0249-2024 | 11-23-2021 | Old Spice Pure Sport 2021 Gift Set, Contains: Old Spice Pure Sport Body Wash 18 Fl Oz (532 mL), 2-in-1 Shampoo & Conditioner 13.5 Fl Oz (400 mL), and Old Spice, SWEAT DEFENSE PURE SPORT PLUS, Dry Spray, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant, Topical spray can, Net WT 3.8 oz (107 g). Dist. by: Procter & Gamble, Cincinnati, OH 45202. Gift Set NDC 69423-590-01, UPC 12044 04853 5 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0254-2024 | 11-23-2021 | Secret, Dry Spray, Aluminum chlorohydrate 23.5% Antiperspirant, Waterlily, Topical Spray Can, Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-381-10; UPC 0 37000 72372 1; 12/pack UPC 0 37000 72991 4 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0255-2024 | 11-23-2021 | Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Lavender, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-383-10, UPC: 0 37000 72986 0 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0242-2024 | 11-23-2021 | Secret, powder fresh, Aluminum chlorohydrate 24%, Anti-Perspirant/Deodorant, Topical spray can Net Wt., (a) 4OZ (113g), NDC 37000-134-11, UPC 0 37000 71109 4, (b) 6OZ (170g), NDC 37000-134-17, UPC 0 37000 71108 7; (c) twin pack-2 each can Net Wt. 6OZ (170g), NDC: 37000-134-01, UPC 0 37000 58690 6; Distr. by: Procter & Gamble, Cincinnati, OH 45202 Package NDCs: 37000-134-11; 37000-134-17; 37000-134-01 | Chemical contamination: presence of benzene | The Procter & Gamble Company / unknown | Class I | Terminated |
| D-0253-2024 | 11-23-2021 | Secret, powder fresh, (Aluminum chlorohydrate 24%), Anti-Perspirant/Deodorant, Topical spray can Net Wt., (a) 4OZ (113g), NDC 37000-134-11, UPC 0 37000 71109 4, (b) 6OZ (170g), NDC 37000-134-17, UPC 0 37000 71108 7; (c) twin pack-2 Topical spray cans, each can Net Wt. 6OZ (170g), NDC: 37000-134-01, UPC 0 37000 58690 6; Dist. by: Procter & Gamble, Cincinnati, OH 45202, Package NDCs: 37000-134-11; 37000-134-17; 37000-134-01 | CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene | The Procter & Gamble Company / unknown | Class II | Terminated |
| D-0264-2022 | 11-19-2021 | Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), packaged in cartons containing 3 wallets of 28 Tablets each, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United Stated, Manufactured by: Lupin Limited, Pithampur, (M.P.) - 454775, India, 244896, The individual wallet NDC 68180-904-11 and the carton NDC 68180-904-13. | Subpotent Drug | Lupin Pharmaceuticals Inc. / 4113 cartons | Class III | Terminated |
| D-0276-2022 | 11-19-2021 | Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY 11722, NDC 31722-997-01. Package NDCs: 31722-996-01; 31722-996-05; 31722-997-01; 31722-997-05 | Product Mix-up | Ascent Pharmaceuticals, Inc. / 9744 bottles | Class II | Terminated |
| D-0266-2022 | 11-19-2021 | AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vitamin E & Moisturizer, 8 FL OZ (237 mL) bottle with either a black or clear top, Distributed by American Screening LLC Shreveport, LA, 71106 UPC 8 40050 51579 2 | Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles. | American Screening LLC / 153,336 bottles | Class I | Completed |
| D-0159-2024 | 11-17-2021 | Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC 0 41388 0041 2, NDC 10157-4645-1) and b) 5.3 oz. aerosol cans (UPC 0 41388 00411 2, NDC 10157-4645-2) Blistex P.O. Box 5392, Oak Brook, IL 60522-5392. Package NDCs: 10157-4645-1; 10157-4645-2 | Chemical contamination: Presence of benzene | Blistex Inc / 243,386 cases (7 6-pack cases; 36 12-pack cases; 2,678,430 cans total) | Class I | Terminated |
| D-0262-2022 | 11-17-2021 | Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, For IM, IV or SC Use Only, Rx only, ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-690-50 | Lack of Assurance of Sterility | ASP CARES / 3077 vials | Class II | Terminated |
| D-0261-2022 | 11-17-2021 | Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, For IM or IV use only, Rx only ASP Cares, 2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-0589-30 | Lack of Assurance of Sterility | ASP CARES / 896 vials | Class II | Terminated |
| D-0260-2022 | 11-17-2021 | Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, For IM, SC or IV Use Only, Rx only, ASP Cares2414 Babcock Rd Ste #106, San Antonio, TX 78229 NDC 72833-565-30 | Lack of Assurance of Sterility | ASP CARES / 1605 vials | Class II | Terminated |
| D-0286-2022 | 11-17-2021 | Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL Syringes, Manufactured for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-02; Carton (10 x 0.4 mL Syringes), Manufactured by Shenzhen Techdow Pharmaceutical Co., Ltd. Shenzhen City, Guangdong Province 518057, China for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-64 | Temperature Abuse; temperature excursion during shipping | Sandoz Inc / 45,036 cartons | Class I | Completed |
| D-0263-2022 | 11-15-2021 | Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by: Aurobindo Pharma USA Inc., 279 Princeton-Hightstown Road, East Windsor, NJ, 08520, Made in India, NDC 65862-143-05 Package NDCs: 65862-142-01; 65862-142-05; 65862-142-99; 65862-143-01; 65862-143-05; 65862-143-99; 65862-144-01; 65862-144-05; 65862-144-99; 65862-145-01; 65862-145-05; 65862-145-99 | Failed Impurities/Degradation Specifications | Aurobindo Pharma USA Inc. / 7296 containers | Class III | Terminated |
| D-0269-2022 | 11-12-2021 | Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, NDC 43598-823-14. Package NDCs: 43598-823-14; 43598-823-31; 43598-823-35 | Failed dissolution specifications | Dr. Reddy's Laboratories, Inc. / 5016 cartons | Class III | Terminated |
| D-0271-2022 | 11-12-2021 | Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152, www.rugbylaboratories.com. NDC 0638-1242-07. | Failed dissolution specifications | Dr. Reddy's Laboratories, Inc. / 2184 cartons | Class III | Terminated |
| D-0267-2022 | 11-12-2021 | Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, 20 Extended-Release Tablets, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-7388-5. Package NDCs: 11822-7388-5 | Failed dissolution specifications | Dr. Reddy's Laboratories, Inc. / 4896 cartons | Class III | Terminated |
| D-0275-2022 | 11-12-2021 | Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ, 08640, Made in India NDC Walmart Inc., Bentonville, AR 72716, Product of India, NDC 43598-823-31. Package NDCs: 43598-823-14; 43598-823-31; 43598-823-35 | Failed dissolution specifications | Dr. Reddy's Laboratories, Inc. / 2,928 cartons | Class III | Terminated |
| D-0273-2022 | 11-12-2021 | Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, 30 Extended-Release Tablets USP, Distributed By CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02985, Made in India, NDC 69842-249-30 | Failed dissolution specifications | Dr. Reddy's Laboratories, Inc. / N/A | Class III | Terminated |
