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-1016-2020 | 10-23-2019 | Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per bottle. [NDC: Brand] NDC CVS Health.: 69842-293-06 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1014-2020 | 10-23-2019 | Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per bottle. [NDC: Brand] NDC Basic Care: 0113-7876-27; NDC CVS Health: 69842-293-27; NDC Leader: 70000-0375-2; NDC Up & Up: 11673-876-27; NDC Walgreens: 0363-1876-27 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-0534-2020 | 10-22-2019 | Cool Mint Tablets Maximum Strength Zantac 150 mg Sanofi Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0120-06, 0597-0120-08, 0597-0120-09, 0597-0120-24, 0597-0120-38, 0597-0120-50, 0597-0120-76, 0597-0120-78, 0597-0120-80, 0597-0120-82, 0597-0120-87. | CGMP Deviations: Presence of NDMA impurity detected in product. | Sanofi-Aventis U.S. LLC / | Class II | Ongoing |
| D-0542-2020 | 10-22-2019 | Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 67751-152-01 67751-152-02 | CGMP Deviations: Presence of NDMA impurity detected in product. | Sanofi-Aventis U.S. LLC / | Class II | Ongoing |
| D-0540-2020 | 10-22-2019 | Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 50269-222-25. | CGMP Deviations: Presence of NDMA impurity detected in product. | Sanofi-Aventis U.S. LLC / | Class II | Ongoing |
| D-0545-2020 | 10-22-2019 | Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 0597-0122-01 0597-0122-08 0597-0122-13 0597-0122-37 0597-0122-40 0597-0122-54 0597-0122-61 0597-0122-81 0597-0122-96 | CGMP Deviations: Presence of NDMA impurity detected in product. | Sanofi-Aventis U.S. LLC / | Class II | Ongoing |
| D-0537-2020 | 10-22-2019 | Regular Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 05269-220-25. | CGMP Deviations: Presence of NDMA impurity detected in product. | Sanofi-Aventis U.S. LLC / | Class II | Ongoing |
| D-0538-2020 | 10-22-2019 | Cool Mint Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's: 41167-0320-1 41167-0320-2 41167-0320-3 41167-0320-4 41167-0320-5 41167-0320-6 41167-0320-7 | CGMP Deviations: Presence of NDMA impurity detected in product. | Sanofi-Aventis U.S. LLC / | Class II | Ongoing |
| D-0543-2020 | 10-22-2019 | Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 68151-2584-0. | CGMP Deviations: Presence of NDMA impurity detected in product. | Sanofi-Aventis U.S. LLC / | Class II | Ongoing |
| D-0536-2020 | 10-22-2019 | Maximum Strength Zantac 150 mg Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 41167-0310-1 41167-0310-2 41167-0310-3 41167-0310-4 41167-0310-6 41167-0310-7 41167-0310-8 | CGMP Deviations: Presence of NDMA impurity detected in product. | Sanofi-Aventis U.S. LLC / | Class II | Ongoing |
| D-0539-2020 | 10-22-2019 | Maximum Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's: 0597-0121-01, 0597-0121-06, 0597-0121-08, 0597-0121-09, 0597-0121-11, 0597-0121-24, 0597-0121-38, 0597-0121-50, 0597-0121-64, 0597-0121-66, 0597-0121-68, 0597-0121-78, 0597-0121-80, 0597-0121-82, 0597-0121-85, 0597-0121-90, 0597-0121-94. | CGMP Deviations: Presence of NDMA impurity detected in product. | Sanofi-Aventis U.S. LLC / | Class II | Ongoing |
| D-0535-2020 | 10-22-2019 | Regular Strength Zantac 75 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219 NDC's 41167-0300-0, 41167-0300-1, 41167-0300-3, 41167-0300-5, 41167-0300-6, 41167-0300-7, 41167-0300-8 | CGMP Deviations: Presence of NDMA impurity detected in product. | Sanofi-Aventis U.S. LLC / | Class II | Ongoing |
| D-0544-2020 | 10-22-2019 | Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC's 66715-9736-2 66715-9736-3 66715-9736-8 | CGMP Deviations: Presence of NDMA impurity detected in product. | Sanofi-Aventis U.S. LLC / | Class II | Ongoing |
| D-0541-2020 | 10-22-2019 | Regular Strength Zantac 150 mg, Distributed by: Chattem, Inc., a Sanofi Company P.O. Box 2219, Chattanooga, TN 37409-0219. NDC 67751-151-01. | CGMP Deviations: Presence of NDMA impurity detected in product. | Sanofi-Aventis U.S. LLC / | Class II | Ongoing |
| D-0351-2020 | 10-22-2019 | Green Lumber Natural Fuel For Men capsule, packaged in packs of 2, 4 and 10 capsules, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660 (949) 426-8622. | Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction. | Green Lumber Holdings, LLC / approx. 30,000 capsules | Class I | Terminated |
| D-0156-2020 | 10-22-2019 | Estradiol Vaginal Inserts USP, 10 mcg, packaged in a) 8-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-71) and b) 18-count Vaginal Inserts (with disposable applicators) per carton (NDC 68462-711-88), Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Colvale-Bardez, Goa 403 513, India; Manufactured for: Glenmark Pharmaceuticals Inc., Mahwah, NJ 07430. Package NDCs: 68462-711-71; 68462-711-88 | Defective Delivery System: complaints for difficulty in pushing the plunger of the applicator. | Glenmark Pharmaceuticals Inc., USA / 216,840 cartons | Class II | Terminated |
| D-0153-2020 | 10-22-2019 | Atorvastatin Calcium Tablets, USP 40 mg*, 1,000 count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326 NDC 60505-2580-8 Package NDCs: 60505-2578-3; 60505-2578-9; 60505-2578-5; 60505-2578-8; 60505-2578-7; 60505-2578-0; 60505-2579-3; 60505-2579-9; 60505-2579-5; 60505-2579-8; 60505-2579-7; 60505-2579-0; 60505-2580-3; 60505-2580-9; 60505-2580-5; 60505-2580-8; 60505-2580-7; 60505-2580-0; 60505-2671-3; 60505-2671-9; 60505-2671-5; 60505-2671-8; 60505-2671-7; 60505-2671-0 | Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg. | Apotex Inc. / 1968 bottles | Class III | Terminated |
| D-0154-2020 | 10-21-2019 | PF-Succinylcholine Chloride Injection, USP 20 mg/mL (200 mg/10 mL), Rx Only, Single-Dose Container, 5 x 10 mL pre-filled syringes, Nephron 503B Outsourcing Facility 4500 12th St. Ext West Columbia, SC 29172, NDC 69374-919-10. | Incorrect labeling: Incorrect or missing lot and/or exp date | Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center / 19,390 syringes | Class III | Terminated |
| D-0155-2020 | 10-18-2019 | Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93 Package NDCs: 0378-5185-93; 0378-5186-93 | Failed Dissolution Specification: Low out of specification dissolution results. | Mylan Pharmaceuticals Inc. / 4,272 bottles | Class II | Terminated |
| D-0195-2020 | 10-18-2019 | BIOGENYX True Full Spectrum CBD Oil Wintergreen, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075 | Marketed without an Approved NDA/ANDA | Basic Reset Inc. / 25 bottles | Class II | Terminated |
| D-0194-2020 | 10-18-2019 | Basic Reset CBD Reset 2400, True Full Spectrum Natural (unflavored), 2400 mg CBD, 1 fl. oz. (29 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075 | Marketed without an Approved NDA/ANDA | Basic Reset Inc. / 391 bottles | Class II | Terminated |
| D-0196-2020 | 10-18-2019 | BIOGENYX True Full Spectrum CBD Oil Natural Flavor, 1 fl. oz. (30 mL) bottle, 2400 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075 | Marketed without an Approved NDA/ANDA | Basic Reset Inc. / 25 bottles | Class II | Terminated |
| D-0191-2020 | 10-18-2019 | Basic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075 | Marketed without an Approved NDA/ANDA | Basic Reset Inc. / 554 bottles | Class II | Terminated |
| D-0188-2020 | 10-18-2019 | Miracle Facelift Masque, All Natural, The Miracle in a Bottle, 2 fl. oz./60 mL bottle, Kim Kaufman Productions Nashville, TN. | Marketed without an Approved NDA/ANDA | Basic Reset Inc. / N/A | Class II | Terminated |
| D-0192-2020 | 10-18-2019 | Basic Reset CBD Reset 750 True Full Spectrum Cinnamon, 750 mg CBD, 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075 | Marketed without an Approved NDA/ANDA | Basic Reset Inc. / 598 bottles | Class II | Terminated |
| D-0187-2020 | 10-18-2019 | Basic Reset Earth Wash Cleaner and Personal Care, Eco Friendly, Non Toxic, 2 fl.oz. bottle, Distributed by: Basic Reset Hendersonville, TN 37075. | Marketed without an Approved NDA/ANDA | Basic Reset Inc. / 949 bottles | Class II | Terminated |
| D-0190-2020 | 10-18-2019 | Nuovi Firming Masque, Renew and Reset, 2 fl. oz. 59 mL bottle, Made in USA exclusively for Basic Reset 260 W. Main St., Ste 103 Hendersonville, TN 37075 | Marketed without an Approved NDA/ANDA | Basic Reset Inc. / 339 bottles | Class II | Terminated |
| D-0197-2020 | 10-18-2019 | BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 mg, Distributed by: Biogenyx, Inc. Hendersonville, TN 37075 | Marketed without an Approved NDA/ANDA | Basic Reset Inc. / 25 bottles | Class II | Terminated |
| D-0189-2020 | 10-18-2019 | Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Distributed by: Basic Reset Hendersonville, TN 37075 | Marketed without an Approved NDA/ANDA | Basic Reset Inc. / 1000 bottles | Class II | Terminated |
| D-0193-2020 | 10-18-2019 | Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. oz. (30 mL) bottle, Distributed by: Basic Reset Hendersonville, TN 37075 | Marketed without an Approved NDA/ANDA | Basic Reset Inc. / 98 bottles | Class II | Terminated |
| D-0162-2020 | 10-17-2019 | Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, NDC 61314-630-06 Package NDCs: 61314-630-06 | Labeling: Incorrect or missing package insert. | Sandoz Inc / 346,929 bottles | Class III | Terminated |
| D-0163-2020 | 10-17-2019 | Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, Product of India, NDC 61314-672-25. Package NDCs: 61314-672-25 | Labeling: Incorrect or missing package insert. | Sandoz Inc / 76,644 bottles | Class III | Terminated |
| D-0161-2020 | 10-17-2019 | Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina. Package NDCs: 0781-6206-75; 0781-6206-93 | Labeling: Incorrect or missing package insert. | Sandoz Inc / 346,929 bottles | Class III | Terminated |
| D-0165-2020 | 10-17-2019 | AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 42291-736-50 UPC 342291736504 Manufactured for: AvKARE, Inc. Pulaski, TN 38478 | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | AVKARE Inc. / 1351 bottles | Class II | Terminated |
| D-0164-2020 | 10-17-2019 | AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for: AvKARE, Inc. Pulaski, TN 38478 | CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API | AVKARE Inc. / 7293 bottles | Class II | Terminated |
| D-0321-2020 | 10-16-2019 | Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3 Package NDCs: 69238-1174-1; 69238-1174-3; 69238-1175-1; 69238-1175-3; 69238-1017-1; 69238-1017-3; 69238-1176-1; 69238-1176-3 | Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits. | Amneal Pharmaceuticals, Inc. / 2460 cartons/3 blister cards/10 capsules each | Class III | Terminated |
| D-0326-2020 | 10-15-2019 | Viatrexx-Connectissue, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0090, NDC 73069-100-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 24 vials | Class II | Terminated |
| D-0340-2020 | 10-15-2019 | Viatrexx-Arthros, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0030, NDC 73069-035-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 6 vials | Class II | Terminated |
| D-0347-2020 | 10-15-2019 | Viatrexx-Male+, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0400, NDC 73069-320-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 2 vials | Class II | Terminated |
| D-0343-2020 | 10-15-2019 | Viatrexx-Intra-Cell, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0280, NDC 73069-250-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 8 vials | Class II | Terminated |
| D-0328-2020 | 10-15-2019 | Viatrexx-Ouch, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0500, NDC 73069-402-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 19 vials | Class II | Terminated |
| D-0345-2020 | 10-15-2019 | Viatrexx-Hair, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0251, NDC 73069-206-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 3 vials | Class II | Terminated |
| D-0348-2020 | 10-15-2019 | Viatrexx-ANS/CNS, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0025, NDC 73069-039-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 1 vial | Class II | Terminated |
| D-0332-2020 | 10-15-2019 | Viatrexx-Articula, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0031, NDC 73069-037-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 69 vials | Class II | Terminated |
| D-0333-2020 | 10-15-2019 | Viatrexx-Neuro 3, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0463, NDC 73069-373-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 7 vials | Class II | Terminated |
| D-0339-2020 | 10-15-2019 | Viatrexx-GI, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0211, NDC 73069-189-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 3 vials | Class II | Terminated |
| D-0346-2020 | 10-15-2019 | Viatrexx-Neuro, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0460, NDC 73069-375-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 13 vials | Class II | Terminated |
| D-0342-2020 | 10-15-2019 | Viatrexx-Relief +, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0615, NDC 73069-450-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 1 vial | Class II | Terminated |
| D-0329-2020 | 10-15-2019 | Viatrexx-Ithurts, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0290, NDC 73069-270-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 12 vials | Class II | Terminated |
| D-0336-2020 | 10-15-2019 | Viatrexx-Prolo, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0558, NDC 73069-443-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 42 vials | Class II | Terminated |
| D-0344-2020 | 10-15-2019 | Viatrexx-Facial, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0184, NDC 73069-164-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 13 vials | Class II | Terminated |
| D-0338-2020 | 10-15-2019 | Viatrexx-Mesenchyme, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0092, NDC 73069-102-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 7 vials | Class II | Terminated |
| D-0334-2020 | 10-15-2019 | Viatrexx-Infla, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0279, NDC 73069-249-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 54 vials | Class II | Terminated |
| D-0331-2020 | 10-15-2019 | Viatrexx-Systemic Detox, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0665, NDC 73069-500-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 5 vials | Class II | Terminated |
| D-0335-2020 | 10-15-2019 | Viatrexx-Collagen, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0085, NDC 73069-095-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 22 vials | Class II | Terminated |
| D-0337-2020 | 10-15-2019 | Viatrexx-Lymph 1, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0370, NDC 73069-310-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 3 vials | Class II | Terminated |
| D-0341-2020 | 10-15-2019 | Viatrexx-Immunexx, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0270, NDC 73069-244-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 18 vials | Class II | Terminated |
| D-0330-2020 | 10-15-2019 | Viatrexx-Adipose, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC0008, NDC 73069-024-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 4 vials | Class II | Terminated |
| D-0327-2020 | 10-15-2019 | Viatrexx-MuSkel-Neural, 10 mL Sterile multi-dose vial, Rx only, Viatrexx Bio Incorporated, Newark, DE, USA, 19713, Item: VSPC4020, NDC 73069-347-41. | Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility. | 8046255 Canada Inc. DBA Viatrexx / 61 vials | Class II | Terminated |
| D-0519-2020 | 10-11-2019 | Levetiracetam Injection, 500 mg/5mL, 10 single-use 5 mL vials, Rx only, Manufactured by: Agile Specialties Private Limited Pilot No. 14, Sipcot II, Hosur-635 109 Tamil Nadu, India, Manufactured for: X-Gen Pharmaceuticals, Inc. Big Flats, NY 14814, NDC 39822-4000-1 | Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached. | X-Gen Pharmaceuticals Inc. / 25120 vials | Class III | Terminated |
| D-0160-2020 | 10-10-2019 | Lyophilized Human Chorionic Gonadotropin 5,500 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910 | Lack of Sterility Assurance. | Innoveix Pharmaceuticals Inc / 290 vials | Class II | Terminated |
| D-0158-2020 | 10-10-2019 | Lyophilized Human Chorionic Gonadotropin 5,000 USP Units For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910 | Lack of Sterility Assurance. | Innoveix Pharmaceuticals Inc / 413 vials | Class II | Terminated |
| D-0157-2020 | 10-10-2019 | Lyophilized Chorionic Gonadotropin 11,000 USP Units for Injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910 | Lack of Sterility Assurance. | Innoveix Pharmaceuticals Inc / 3905 vials | Class II | Terminated |
| D-0159-2020 | 10-10-2019 | Lyophilized Sermorelin w/ GHRP2 3 mg For injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910 | Lack of Sterility Assurance. | Innoveix Pharmaceuticals Inc / 1747 vials | Class II | Terminated |
| D-0147-2020 | 10-09-2019 | PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chloride Injection-250 mL Total Dose: (500 mcg/156.3 mg)/250 mL, Rx Only, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC 69374-0525-25 | GMP Deviations: potential glass contamination | Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center / 1855 bags | Class II | Terminated |
| D-0148-2020 | 10-09-2019 | PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride Injection-250 mL, Rx Only Total Dose: (500 mcg/312.5 mg)/250 mL, Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-530-25 | GMP Deviations: potential glass contamination | Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center / 1370 bags | Class II | Terminated |
| D-0149-2020 | 10-09-2019 | PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride Injection-200 mL Total Dose: (400 mcg/200 mg)/200 mL, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-526-20 | GMP Deviations: potential glass contamination | Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center / 615 bags | Class II | Terminated |
| D-0150-2020 | 10-09-2019 | Amino Acid Injection 50 g/1000 mL (50 mg/mL) 25 g L-Arginine HCl; 25 g L-Lysine HCl, Single Dose Container, Rx Only Nephron 503B outsourcing facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-988-10 | Lack of Assurance of Sterility; bags have potential to leak | Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center / 162 bags | Class II | Terminated |
| D-0151-2020 | 10-09-2019 | del Nido Cardioplegia Solution, 1000 mL, Single-Dose Container, Rx Only Nephron 503B Outsourcing Facility 4500 12th St. Extension West Columbia, SC 29172 NDC: 69374-984-10 | Lack of Assurance of Sterility; bags have potential to leak | Nephron Pharmaceuticals Corporation dba Nephron Sterile Compounding Center / 1047 bags | Class II | Terminated |
| D-0146-2020 | 10-09-2019 | Leucovorin Calcium Injection, USP 500 mg*/50 mL (10 mg/mL) 50 mL Single-Dose Vial NDC 50742-464-50 Rx Only Ingenus Pharmaceuticals, LLC. Orlando, FL 32839 | Crystallization: Presence of particulate matter identified as API crystallization | Ingenus Pharmaceuticals Llc / 16485 vials | Class II | Terminated |
| D-0139-2020 | 10-07-2019 | Rifampin for Injection, USP, 600 mg/vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103; NDC 67457-445-60. Package NDCs: 67457-445-60 | Failed Impurities/Degradation Specifications: discoloration due to elevated unknown impurity results which could decrease the effectiveness of the product. | Mylan Laboratories Limited (Sterile Products Division) / 19,165 vials | Class II | Terminated |
| D-0142-2020 | 10-04-2019 | Methylphenidate Hydrochloride Oral Solution 5mg per 5mL, 500 mL Bottle, Sugar Free Alcohol Free, Rx Only, Mfd by: KVK Tech, Inc., Newtown, PA 18940, NDC 10702-0163-50. | Presence of Foreign Substance; Fiber particles. | KVK-Tech, Inc. / 384 bottles | Class III | Terminated |
| D-0136-2020 | 10-02-2019 | 10% LMD in 5% Dextrose Injection Dextran 40 in Dextrose Injection, USP, 500 mL bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7418-13 Package NDCs: 0409-7418-13; 0409-7418-03; 0409-7419-14; 0409-7419-03 | Lack of Assurance of Sterility: Bag has the potential to leak. | Pfizer Inc. / 17832 bags | Class II | Terminated |
| D-0168-2020 | 10-01-2019 | Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129-05) Package NDCs: 55111-129-60; 55111-129-05; 55111-130-30; 55111-130-01 | CGMP Deviations: Presence of NDMA impurity detected in product. | Dr. Reddy's Laboratories, Inc. / N/A | Class II | Completed |
| D-0180-2020 | 10-01-2019 | Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-130-01) Package NDCs: 55111-129-60; 55111-129-05; 55111-130-30; 55111-130-01 | CGMP Deviations: Presence of NDMA impurity detected in product. | Dr. Reddy's Laboratories, Inc. / N/A | Class II | Completed |
| D-0178-2020 | 10-01-2019 | Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC. | CGMP Deviations: Presence of NDMA impurity detected in product. | Dr. Reddy's Laboratories, Inc. / N/A | Class II | Completed |
| D-0182-2020 | 10-01-2019 | Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC) Package NDCs: 55111-404-34; 55111-404-32; 55111-404-36; 55111-404-50; 55111-404-61; 55111-404-55; 55111-404-62; 55111-404-90; 55111-404-02; 55111-404-65; 55111-404-17; 55111-404-24; 55111-404-38; 55111-404-40 | CGMP Deviations: Presence of NDMA impurity detected in product. | Dr. Reddy's Laboratories, Inc. / N/A | Class II | Completed |
| D-0177-2020 | 10-01-2019 | Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 71713-203-02), b.)95 count bottles (NDC 71713-203-05) (Thirty Madison) OTC. | CGMP Deviations: Presence of NDMA impurity detected in product. | Dr. Reddy's Laboratories, Inc. / N/A | Class II | Completed |
| D-0172-2020 | 10-01-2019 | Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 30142-505-34), b.) 50 count bottles (NDC 30142-505-50) (Kroger) OTC | CGMP Deviations: Presence of NDMA impurity detected in product. | Dr. Reddy's Laboratories, Inc. / N/A | Class II | Completed |
| D-0171-2020 | 10-01-2019 | Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count bottles (NDC 49035-404-13) c.) 220 count bottles (NDC 49035-404-65) (Walmart) OTC | CGMP Deviations: Presence of NDMA impurity detected in product. | Dr. Reddy's Laboratories, Inc. / N/A | Class II | Completed |
| D-0324-2020 | 10-01-2019 | WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets, packaged in a) 12 count (NDC 0363-1407-01, UPC 3 11917-18328 2 ) and b) 18-count boxes (NDC 0363-1407-02, UPC 3 11917-20318 8) Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, Package NDCs: 0363-1407-01; 0363-1407-02 | Subpotent Drug | Sato Pharmaceutical Inc. / a) 112,104 units b) 24,696 units | Class III | Terminated |
| D-0183-2020 | 10-01-2019 | Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC | CGMP Deviations: Presence of NDMA impurity detected in product. | Dr. Reddy's Laboratories, Inc. / N/A | Class II | Completed |
| D-0176-2020 | 10-01-2019 | Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) OTC. | CGMP Deviations: Presence of NDMA impurity detected in product. | Dr. Reddy's Laboratories, Inc. / N/A | Class II | Completed |
| D-0181-2020 | 10-01-2019 | Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC) Package NDCs: 55111-131-30; 55111-131-60; 55111-131-80; 55111-131-90; 55111-131-04; 55111-131-37; 55111-131-79; 55111-131-14; 55111-131-81; 55111-131-45 | CGMP Deviations: Presence of NDMA impurity detected in product. | Dr. Reddy's Laboratories, Inc. / N/A | Class II | Completed |
| D-0184-2020 | 10-01-2019 | Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC | CGMP Deviations: Presence of NDMA impurity detected in product. | Dr. Reddy's Laboratories, Inc. / N/A | Class II | Completed |
| D-0174-2020 | 10-01-2019 | Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger) | CGMP Deviations: Presence of NDMA impurity detected in product. | Dr. Reddy's Laboratories, Inc. / N/A | Class II | Completed |
| D-0175-2020 | 10-01-2019 | Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC | CGMP Deviations: Presence of NDMA impurity detected in product. | Dr. Reddy's Laboratories, Inc. / N/A | Class II | Completed |
| D-0179-2020 | 10-01-2019 | Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC. | CGMP Deviations: Presence of NDMA impurity detected in product. | Dr. Reddy's Laboratories, Inc. / N/A | Class II | Completed |
| D-0169-2020 | 10-01-2019 | Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC, NDC 150062076 UPC Code 078742089720 | CGMP Deviations: Presence of NDMA impurity detected in product. | Dr. Reddy's Laboratories, Inc. / N/A | Class II | Completed |
| D-0323-2020 | 10-01-2019 | Motion Sickness (meclizine hydrochloride) 25 mg tablets, 12-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 59779-534-01. UPC 050428345535 Package NDCs: 59779-534-01; 0504283455 | Subpotent Drug | Sato Pharmaceutical Inc. / 210,744 units | Class III | Terminated |
| D-0185-2020 | 10-01-2019 | Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC | CGMP Deviations: Presence of NDMA impurity detected in product. | Dr. Reddy's Laboratories, Inc. / N/A | Class II | Completed |
| D-0170-2020 | 10-01-2019 | Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 0363-0010-34), b.) 65 count bottles (NDC 0363-0010-61) , c.) 95 count bottles (NDC 0363-0010-62), d.) 200 count bottles (NDC 0363-0010-01) (Walgreens) OTC | CGMP Deviations: Presence of NDMA impurity detected in product. | Dr. Reddy's Laboratories, Inc. / N/A | Class II | Completed |
| D-0173-2020 | 10-01-2019 | Ranitidine Tablets, USP 75 mg, a.) 30 count bottles (NDC 69842-871-30) b.) 80 count bottles (NDC 69842-871-80) c.)160 count bottles (NDC 69842-871-37) (CVS) OTC | CGMP Deviations: Presence of NDMA impurity detected in product. | Dr. Reddy's Laboratories, Inc. / N/A | Class II | Completed |
| D-0303-2020 | 10-01-2019 | Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, 150-count bottles, Manufactured by SATO PHARMACEUTICAL CO., LTD., 1-5-27 Motoakasaka Minato-KU Tokyo, Japan; SATO PHARMACEUTICAL, INC., 20695 S. Western Ave., Suite 240, Torrance, CA 90501; NDC 49873-404-01. Package NDCs: 49873-404-01 | Subpotent Drug: Formulated amount of sennosides component is less than labelled claim. | Sato Pharmaceutical Inc. / 17,284 bottles | Class III | Terminated |
| D-0325-2020 | 10-01-2019 | Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 69842-288-01. UPC 5042849946 | Subpotent Drug | Sato Pharmaceutical Inc. / 39,504 units | Class III | Terminated |
| D-0322-2020 | 10-01-2019 | Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distributed by Sato Pharmaceutical INC. 20695 S. Western Ave., Suite 240 Torrence, CA 90501, NDC 49873-803-01. UPC 4987301603 | Subpotent Drug | Sato Pharmaceutical Inc. / 21,864 units | Class III | Terminated |
| D-0523-2020 | 10-01-2019 | Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injection Solution, 10 mL per vial, New Vitalis Pharmacy | Lack of sterility assurance. | New Vitalis Pharmacy LLC dba New Vitalis Pharmacy / 2981.62 mL | Class II | Terminated |
| D-0302-2020 | 09-27-2019 | Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz.(120 mL), Distributed by: Winco Foods, LLC, Boise, ID 83704, NDC 67091-321-04 | Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. | Taro Pharmaceuticals U.S.A., Inc. / 5,280 bottles | Class II | Terminated |
| D-0167-2020 | 09-27-2019 | Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose, Rx only, Mfd. for: Wilshire Pharmaceuticals, Inc. Atlanta, GA 30328. NDC 52536-625-01 Package NDCs: 52536-625-01; 52536-625-10 | Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL single-does vials | Arbor Pharmaceuticals Inc. / 67934 units | Class III | Terminated |
| D-0301-2020 | 09-27-2019 | Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(240 mL), Distributed by: Taro Pharmaceuticals, U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-1 Package NDCs: 51672-2130-8; 51672-2130-1 | Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert plastic material introduced during manufacturing. | Taro Pharmaceuticals U.S.A., Inc. / 5,190 bottles | Class II | Terminated |
