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-0385-2022 | 01-04-2022 | CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablets per box, UPC 050428290538, Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI, 02895, Made in India. | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 41,784 boxes | Class III | Terminated |
| D-0378-2022 | 01-04-2022 | Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 0363-1606-20, b) 30 Extended Release Tablets per box, NDC 0363-1606-30, Distributed by: Walgreen Co, 200 Wilmot Rd., Deerfield, IL 60015, Made in India. Package NDCs: 0363-1606-30; 0363-1606-20 | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 67,848 boxes | Class III | Terminated |
| D-0380-2022 | 01-04-2022 | Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP, 20 Extended-Release Tablets per box, UPC 011822738873, Distributed by Rite Aid, 30 United Lane, Camp Hill, PA 17011, Made in India. | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 7,080 boxes | Class III | Terminated |
| D-0382-2022 | 01-04-2022 | Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC 343598823355, b) 20 tablets per box, UPC 343598823140, c) 30 tablets per box, UPC 343598823317, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Made in India. | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 9,912 boxes | Class III | Terminated |
| D-0384-2022 | 01-04-2022 | QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd, Novi, MI 48375, Made in India. | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 9,984 boxes | Class III | Terminated |
| D-0381-2022 | 01-04-2022 | Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended-Release Tablets USP, 20 tablets per box, NDC 30142-611-14, Distributed by the Kroger Co., Cincinnati, Ohio, 45202, Made in India. Package NDCs: 30142-611-14 | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 11,064 boxes | Class III | Terminated |
| D-0383-2022 | 01-04-2022 | equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant Extended-Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 49035-273-20, b) 30 Extended Release Tablets per box, NDC 49035-273-30, Distributed by: Walmart Inc., Bentonville, AR 72716, Product of India. | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 137,856 boxes | Class III | Terminated |
| D-0379-2022 | 01-04-2022 | Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI, 49152, Made in India. | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 2,352 boxes | Class III | Terminated |
| D-0386-2022 | 01-04-2022 | Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Release Tablets per box, NDC 70000-0518-1, Distributed by Cardinal Health, Dublin, Ohio 43077, Made in India. | Failed Dissolution Specifications | Dr. Reddy's Laboratories, Inc. / 10,536 boxes | Class III | Terminated |
| D-0362-2022 | 12-31-2021 | Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: Rubicon Research Prvate Limited Ambernath, Dist. Thane, 421506 India. NDC 52817-360-00 Package NDCs: 52817-362-10; 52817-362-00; 52817-359-10; 52817-359-50; 52817-361-10; 52817-361-00; 52817-360-10; 52817-360-00; 52817-358-10; 52817-358-50 | Complaint received of foreign matter (metal) embedded in tablet. | Rubicon Research Private Limited / 3,684 1000-count bottles | Class II | Terminated |
| D-0371-2022 | 12-31-2021 | Norepinephrine Bitartrate Injection USP 4 mg/4 mL (1 mg/mL), 4 mL Single-Dose Vials, 10 vials per carton, Rx Only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0703-1153-03. | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 11,450 vials | Class II | Terminated |
| D-0370-2022 | 12-31-2021 | MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/10mL (40mg/mL), 10 mL Multiple-Dose Vial, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 16714-090-01, packaged in cartons. | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 7,400 cartons | Class II | Terminated |
| D-0366-2022 | 12-30-2021 | Metformin 750 mg Extended Release NDC # 70518-2920-00 | CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. | RemedyRepack Inc. / 56 Blister Cards | Class II | Terminated |
| D-0360-2022 | 12-29-2021 | Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03), Rx only, MFG: Ascend Labs, LLC, Montvale, NJ 07645 | Failed Impurities/Degradation Specifications | RemedyRepack Inc. / a) 716 bottles/ 1432 capsules b) 223 blister packs/ 466 capsules | Class II | Terminated |
| D-0450-2022 | 12-29-2021 | Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05 Package NDCs: 57237-219-30; 57237-219-90; 57237-219-05; 57237-220-30; 57237-220-90; 57237-220-05; 57237-221-30; 57237-221-90; 57237-221-05 | Superpotent and Failed Tablet/Capsule Specifications | Aurobindo Pharma USA Inc. / 792 bottles | Class II | Terminated |
| D-0358-2022 | 12-29-2021 | Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-01 Package NDCs: 43386-432-01; 43386-432-03; 43386-432-05; 43386-433-01; 43386-433-03; 43386-433-05; 43386-430-01; 43386-430-05; 43386-430-03; 43386-434-01; 43386-434-05; 43386-434-03; 43386-431-01; 43386-431-03; 43386-431-05 | Out-of-specification impurity test result observed at 18-month long term stability time point. | Lupin Pharmaceuticals Inc. / 23,965 100 count bottles | Class III | Terminated |
| D-0392-2022 | 12-27-2021 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01 Package NDCs: 72578-035-01; 72578-035-05; 72578-036-01; 72578-036-05 | CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. | VIONA PHARMACEUTICALS INC / 23,8416/100 count bottles | Class II | Terminated |
| D-0372-2022 | 12-27-2021 | Nitroglycerin Lingual Spray, 400 mcg per spray, 200 metered sprays, 12 g bottles, Rx only, Manufactured by Perrigo, Yeruham, Israel; Distributed by Perrigo, Allegan, MI 49010, NDC 45802-210-02 Package NDCs: 45802-210-01; 45802-210-02 | Defective Delivery System | Padagis US LLC / 11,868 bottles | Class II | Terminated |
| D-0326-2022 | 12-22-2021 | Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01. | Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration. | Lupin Pharmaceuticals Inc. / 50,832 bottles | Class III | Terminated |
| D-0377-2022 | 12-21-2021 | SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per carton, Mfg for: AvKARE, TN 38478, NDC 50262-731-24. | Microbial Contamination of Non-Sterile Product | Lohxa, LLC / 87,840 unit dose cups | Class I | Terminated |
| D-0463-2022 | 12-21-2021 | Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 Morris Ave, Union, NJ 07083 | Lack of Assurance of Sterility | Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy / 57,994 vials | Class II | Ongoing |
| D-0359-2022 | 12-21-2021 | Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50 Package NDCs: 67877-584-50; 67877-584-01; 67877-584-05; 67877-584-33 | Failed impurities/degradation specifications | Ascend Laboratories, LLC / 42,698 bottles | Class II | Terminated |
| D-0451-2022 | 12-20-2021 | Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03 Package NDCs: 68001-500-00; 68001-500-03; 68001-500-08; 68001-501-00; 68001-501-03; 68001-501-08; 68001-502-00; 68001-502-03; 68001-502-08; 68001-503-00 | Failed Dissolution Specifications | American Health Packaging / 6,637 500-count bottles | Class II | Terminated |
| D-0294-2022 | 12-16-2021 | Penicillin V Potassium for Oral Solution, USP 125 mg (200,000 U) per 5 mL a) 100 mL (NDC 00093-4125-73) and b) 200 mL (NDC 00093-4125-74) (when mixed) bottles, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 | Subpotent | Teva Pharmaceuticals USA / a) 86,790 and b) 25,416 bottles | Class II | Terminated |
| D-0375-2022 | 12-15-2021 | Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3 Package NDCs: 51672-1294-1; 51672-1294-2; 51672-1294-3; 51672-1258-1; 51672-1258-2; 51672-1258-6; 51672-1258-3; 51672-1259-1; 51672-1259-2; 51672-1259-6; 51672-1259-3 | Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria | Taro Pharmaceuticals U.S.A., Inc. / 96 tubes | Class I | Terminated |
| D-0373-2022 | 12-08-2021 | Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper bottles (NDC 0591-2127-12), Rx Only, Manufactured in India By: Indoco Remedies Limited Verna, Goa - 403722, India, Manufactured For: Teva Pharmaceuticals USA, Inc. Parsippany, NJ | Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing. | Teva Pharmaceuticals USA / a) 66,099 dropper bottles; b) 21,243 dropper bottles | Class II | Terminated |
| D-0714-2022 | 12-07-2021 | Diclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA Pharmaceuticals Baton Rouge, LA, NDC 61919-675-05 | Defective Container: Leaking containers. | Direct Rx / 312 bottles | Class II | Terminated |
| D-0559-2022 | 12-06-2021 | NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cream, 4 oz tubes, Manufactured for NaturesPlus 548 Broadhollow Road, Melville, NY 11747, USA | MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae. | Organics Corporation of America DBA Ambix Laboratories / 4,214 tubes | Class II | Ongoing |
| D-0391-2022 | 12-06-2021 | Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404 | CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices. | Medique Products / 6,639,838 tablets | Class II | Terminated |
| D-0390-2022 | 12-06-2021 | Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged in 2-count Tablets per Unit Dose Packet, packaged as a) 200-count Tablets (100 x 2) Unit Dose packets per carton, UPC 3 47682 22847 7, Reorder #22847; b) 500-count Tablets (250 x 2) Unit Dose packets per carton, UPC 3 47682 22813 2, Reorder #22813; c) 100-count Tablets (50 x 2) Unit Dose packets per carton, UPC 3 47682 22833 0, Reorder #22833; d) 24-count Tablets (12 x 2) Unit Dose packets per carton, UPC 3 47682 22864 4, Reorder #22864; Manufactured for Medique Products, Fort Myers, FL 33967. | CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices. | Medique Products / 16,630,118 tablets | Class II | Terminated |
| D-0389-2022 | 12-06-2021 | Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count Tablets (50 Packets, 2 tablets each) per carton, Manufactured for: Acme United Corporation 55 Walls Dr, Fairfield, CT 06824, UPC 0 73577 90316 6 | CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices. | Medique Products / 3,260,400 tablets | Class II | Terminated |
| D-0363-2022 | 12-06-2021 | kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottles, Distributed by: Valisa MFG, LLC, Farmingdale, NY, 11735, Made in USA, UPC 6 86162 99246 1 | Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol | Valisa MFG LLC / 7704 bottles | Class I | Terminated |
| D-0399-2022 | 12-06-2021 | Dexamethasone sodium phosphate, sterile otic solution for injection Preservative free, 19.2 mg/0.8mL (24mg/mL), 0.8 mL per syringe Single Use Syringe For Otic Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0848-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 323 syringes | Class II | Terminated |
| D-0425-2022 | 12-06-2021 | Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Single Use Bag for IV Injection (Preservative Free), 250 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1456-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 1795 bags | Class II | Terminated |
| D-0431-2022 | 12-06-2021 | CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphotericin B Otic Powder, 50mg / 30mg / 5mg, 5 count bottle, For Otic Use with Insufflator, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1633-05 | CGMP Deviations | Edge Pharma, LLC / 1055 bottles | Class II | Terminated |
| D-0443-2022 | 12-06-2021 | Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, NDC 05446-1211-03 | CGMP Deviations | Edge Pharma, LLC / 1861 jars | Class II | Terminated |
| D-0440-2022 | 12-06-2021 | Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% / 4%, Spearmint-Peppermint, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-0407-10 | CGMP Deviations | Edge Pharma, LLC / 221 jars | Class II | Terminated |
| D-0449-2022 | 12-06-2021 | Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01 | CGMP Deviations | Edge Pharma, LLC / | Class II | Terminated |
| D-0416-2022 | 12-06-2021 | Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446 NDC 05446-1544-10 | Lack of Assurance of Sterility | Edge Pharma, LLC / 6535 vials | Class II | Terminated |
| D-0413-2022 | 12-06-2021 | Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1476-05, packaged in vials. | Lack of Assurance of Sterility | Edge Pharma, LLC / 309 vials | 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-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-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-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-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-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-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-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-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-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-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-0407-2022 | 12-06-2021 | Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1416-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 860 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-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-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-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-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-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-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-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-0424-2022 | 12-06-2021 | Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free, 8 mg/0.8mL (10 mg/mL) (vancomycin equivalent), 0.8 mL per syringe, Single Use Syringe, For Intraocular Injection, Edge Pharma LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0736-01 | Lack of Assurance of Sterility | Edge Pharma, LLC / 3360 syringes | 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
