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-0522-2020 | 11-11-2019 | Amiodarone Hydrochloride Injection, USP, 900 mg per 18 mL (50 mg / mL), 18 mL Multiple Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-182-18 Package NDCs: 55150-180-03; 55150-181-09; 55150-182-18 | Crystallization: Presence of visible particulate matter. | AuroMedics Pharma LLC / 138,720 vials | Class III | Terminated |
| D-0521-2020 | 11-11-2019 | Amiodarone Hydrochloride Injection, USP, 450 mg per 9 mL (50 mg / mL), 9 mL Single Dose Vial, Rx only, Distributed by AuroMedics Pharma LLC E. Windsor, NJ. 08520, Made in India. NDC 55150-181-09 Package NDCs: 55150-180-03; 55150-181-09; 55150-182-18 | Crystallization: Presence of visible particulate matter. | AuroMedics Pharma LLC / 29,830 vials | Class III | Terminated |
| D-0505-2020 | 11-08-2019 | StellaLife VEGA Oral Gel Rinse (In equal parts of: Azadirachta Indica 1x, Calendula Officinalis 1x, Echinacea Purpurea 1x, Plantago Major 1x), packaged in 1000 mL white plastic bottle. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 1 bottle/ | Class II | Terminated |
| D-0503-2020 | 11-08-2019 | Silicea 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64199 6. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 426 bottles | Class II | Terminated |
| D-1037-2020 | 11-08-2019 | Bow & Arrow, Dietary Supplement, Libido Enhancer for Men, a) Four pack, b) Ten pack capsules per carton, Exclusively Manufactured by: Medicine Man Distribution, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783 | Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis. | Med Man Distribution, Inc. / 1880 cartons | Class I | Terminated |
| D-0504-2020 | 11-08-2019 | Pareira (Brava) 1X Tincture, 50 mL bottle, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 1 bottle | Class II | Terminated |
| D-0494-2020 | 11-08-2019 | Cell Salts Combination 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64200 9. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 829 bottles | Class II | Terminated |
| D-0491-2020 | 11-08-2019 | Calcarea Fluorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64188 0. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 489 bottles | Class II | Terminated |
| D-0506-2020 | 11-08-2019 | R2103, Active Ingredients: Berberis Aquifolium 3x; Borax 3; , Kreosotum 10X; Sepia 3x. Inactive ingredient: 28% dilution alcohol, packaged in a) 470 mL bottle and b) 1000 mL bottle; Manufactured for Wisconsin Pharmacal Company, By: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / a) 1 bottle; b) 11 bottles | Class II | Terminated |
| D-0497-2020 | 11-08-2019 | Kali Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64195 8. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 417 bottles | Class II | Terminated |
| D-1036-2020 | 11-08-2019 | UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) four pack, c) ten pack capsules per carton, Exclusively Manufactured and Formulated by: Buy Wise Marketing, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783, Ultimatepleasure2.com. | Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis. | Med Man Distribution, Inc. / 1,680 cartons | Class I | Terminated |
| D-0493-2020 | 11-08-2019 | Calcarea Sulphurica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64190 3. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 300 bottles | Class II | Terminated |
| D-0492-2020 | 11-08-2019 | Calcarea Phosphorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64189 7. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 681 bottles | Class II | Terminated |
| D-0501-2020 | 11-08-2019 | Natrum Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64192 7. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 366 bottles | Class II | Terminated |
| D-0496-2020 | 11-08-2019 | Kali Muriaticum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64194 1. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 300 bottles | Class II | Terminated |
| D-0498-2020 | 11-08-2019 | Kali Sulphuricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64196 5. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 295 bottles | Class II | Terminated |
| D-0495-2020 | 11-08-2019 | Ferrum Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64198 9. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 462 bottles | Class II | Terminated |
| D-0499-2020 | 11-08-2019 | Magnesia Phosphorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64197 2. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 487 bottles | Class II | Terminated |
| D-0500-2020 | 11-08-2019 | Natrum Muriaticum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64191 0. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 366 bottles | Class II | Terminated |
| D-0502-2020 | 11-08-2019 | Natrum Sulphuricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64193 4. | CGMP Deviations: products were not manufactured under current good manufacturing practices. | Washington Homeopathic Products, Inc. / 288 bottles | Class II | Terminated |
| D-0308-2020 | 11-06-2019 | GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA. | CGMP Deviations: Presence of NDMA impurity detected in product. | Golden State Medical Supply Inc. / N/A | Class II | Terminated |
| D-0307-2020 | 11-06-2019 | GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA. | CGMP Deviations: Presence of NDMA impurity detected in product. | Golden State Medical Supply Inc. / N/A | Class II | Terminated |
| D-0530-2020 | 11-06-2019 | Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-05 | CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. | AuroMedics Pharma LLC / 26,736 bottles | Class II | Ongoing |
| D-0526-2020 | 11-06-2019 | DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79 | CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. | AuroMedics Pharma LLC / 69,696 bottles | Class II | Ongoing |
| D-0529-2020 | 11-06-2019 | Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74 | CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. | AuroMedics Pharma LLC / 19320 bottles | Class II | Ongoing |
| D-0527-2020 | 11-06-2019 | Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60 | CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. | AuroMedics Pharma LLC / 45,456 bottles | Class II | Ongoing |
| D-0528-2020 | 11-06-2019 | Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30 | CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups. | AuroMedics Pharma LLC / 134,160 bottles | Class II | Ongoing |
| D-0518-2020 | 11-04-2019 | Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for: Actavis Laboratories FL. Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-2579-20 Package NDCs: 0591-2579-20 | Presence of foreign substance: Brown/black particles found during stability testing. | Teva Pharmaceuticals USA, Inc. / 3,623 bottles | Class II | Terminated |
| D-0305-2020 | 11-01-2019 | Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-723-10 Package NDCs: 68180-722-20; 68180-722-10; 68180-722-04; 68180-722-05; 68180-723-20; 68180-723-10; 68180-723-04; 68180-723-05 | Presence of Foreign substance: identified as a dead ant. | Lupin Pharmaceuticals Inc. / 30,516 bottles | Class III | Terminated |
| D-0532-2020 | 11-01-2019 | Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. by: KVK-Tech, Inc. Newtown PA 18940; NDC 10702-150-16 Package NDCs: 10702-150-16 | Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection | KVK-Tech, Inc. / 1534 bottles | Class II | Terminated |
| D-0306-2020 | 11-01-2019 | Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA Package NDCs: 68180-722-20; 68180-722-10; 68180-722-04; 68180-722-05; 68180-723-20; 68180-723-10; 68180-723-04; 68180-723-05 | Presence of Foreign substance: identified as a dead ant. | Lupin Pharmaceuticals Inc. / a) 4074 bottles b) 30,300 bottles | Class III | Terminated |
| D-0631-2020 | 11-01-2019 | Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69) | CGMP Deviations: Presence of NDMA impurity detected in product. | American Health Packaging / 1,692 cases of 40 and 50 cups | Class II | Terminated |
| D-0304-2020 | 11-01-2019 | Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-0441-02 | Presence of Foreign substance: identified as a dead ant. | Lupin Pharmaceuticals Inc. / 28,254 bottles | Class III | Terminated |
| D-0533-2020 | 10-31-2019 | LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Powders for Gel: Lidocaine Hydrochloride - 4 g, Ephinephrine Bitartrate - 180 mg, Tetracaine Hydrochloride - 500 mg, Sodium Metabisulfite - 75 mg, SuturaGel Methlcellulose Base; RX Only, For Prescription Compounding, Fagron, Inc., 2400 Pilot Knob Rd, St. Paul, MN 55120. NDC: 51552-1539-1 | Microbial contamination of non-sterile product. | Fagron, Inc / 11,912 kits | Class II | Terminated |
| D-0575-2020 | 10-30-2019 | Potassium Phosphate, Monobasic, Crystal, NF, Multi-Compendial, Bulk Pharmaceutical Chemical, packaged in a) 500G glass bottles, product number 3248-01, NDC 10106-3248-1; b) 2.5KG glass bottles, product number 3248-05, NDC 10106-3248-2; c) 12KG pails, product number 3248-07, NDC 10106-3248-3; d) 1KT bottles and drums, product number 3248-X2; e) 1KT bottles and drums, product number 3248-X3; f) 12KG pails, product number 7390-19; Avantor Performance Materials, LLC, 100 Matsonford, Road, Suite 200, Radnor, PA 19087. | Failed Stability Specifications: Product exceeds compendia and firm's specifications for iron content. | Avantor Performance Materials Inc / a) 36 bottles; b) 85 bottles; c) 43 pails; d) 28 bottles and drums; e) 100 bottles and drums; f) 4 pails | Class II | Terminated |
| D-0309-2020 | 10-28-2019 | Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 NDC 54838-550-80 | CGMP Deviations: Presence of NDMA impurity detected in product. | Lannett Company, Inc. / 683,149 bottles | Class II | Terminated |
| D-0311-2020 | 10-25-2019 | Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-40 | CGMP Deviations: Presence of NDMA impurity detected in product. | Novitium Pharma LLC / 2718 bottles | Class II | Terminated |
| D-0349-2020 | 10-25-2019 | LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03 | Presence of Particulate Matter. | ICU Medical Inc / 389,808 bags | Class I | Terminated |
| D-0350-2020 | 10-25-2019 | 0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25 | Presence of Particulate Matter. | ICU Medical Inc / 58,464 bags | Class I | Terminated |
| D-0312-2020 | 10-25-2019 | Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-10 | CGMP Deviations: Presence of NDMA impurity detected in product. | Novitium Pharma LLC / 12312 bottles | Class II | Terminated |
| D-0313-2020 | 10-25-2019 | Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-40 | CGMP Deviations: Presence of NDMA impurity detected in product. | Novitium Pharma LLC / 6660 bottles | Class II | Terminated |
| D-0310-2020 | 10-25-2019 | Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-20 | CGMP Deviations: Presence of NDMA impurity detected in product. | Novitium Pharma LLC / 19560 bottles | Class II | Terminated |
| D-0186-2020 | 10-23-2019 | Alprazolam Tablets, USP 0.5 mg, 500-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 Made in Australia, NDC 0378-4003-05 | Presence of Foreign Substance | Mylan Pharmaceuticals Inc. / 5,760 bottles | Class II | Terminated |
| D-1012-2020 | 10-23-2019 | Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per bottle. [NDC: Brand] NDC CVS Health: 69842-293-65; NDC Equaline 41163-931-65; NDC Family Wellness: 55319-876-65; NDC Good Sense 0113-0876-65; NDC H.E.B.: 37808-876-65; NDC Harris Teeter: 69256-876-65; NDC Health Mart: 62011-0283-1; NDC Leader: 62011-0283-1; NDC Major: 0904-6715-46; NDC Signature Care: 21130-118-65; NDC Sunmark: 49348-136-44; NDC Up & Up: 11673-876-65; NDC Walgreens: 0363-1876-65 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1013-2020 | 10-23-2019 | Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per bottle. [NDC: Brand] NDC Health Mart: 62011-0283-2; NDC Major: 0904-6715-52; NDC Meijer: 41250-252-72; NDC Sunmark: 49348-136-12; | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1027-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-01; NDC CVS Health: 59779-950-01 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1017-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [NDC: Brand] NDC Good Sense:0113-0852-51; NDC Walgreens 0363-0852-51 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1026-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-01; NDC Berkley Jensen: 68391-852-56; NDC: CVS Health: 59779-540-01; NDC DG Health: 55910-011-01; NDC Kirkland: 63981-852-56; NDC Kroger: 30142-600-56; NDC Meijer: 41250-852-01; NDC Rite Aid: 11822-0852-4; NDC Walgreens: 0363-0852-01 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1015-2020 | 10-23-2019 | Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per bottle. [NDC: Brand] NDC H.E.B.: 37808-876-47; NDC Equate: 49035-876-47 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1023-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7950-09; NDC CVS Health: 59779-950-09; NDC Equate: 49035-800-09; NDC Good Neighbor Pharmacy: 46122-533-09; NDC Kroger: 30142-891-09; NDC Topcare: 36800-950-09; NDC Up & Up: 11673-950-09; NDC Walgreens: 0363-0950-09 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1019-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Care One: 41520-609-62; NDC CVS Health: 59779-950-62; NDC DG Health: 55910-423-62; NDC Equaline: 41163-950-62; NDC Family Wellness: 55319-523-62; NDC Good Neighbor Pharmacy: 46122-041-62; NDC HEB: 37808-710-02; NDC Kroger: 30142-891-02; NDC Leader: 70000-0378-1; NDC Meijer: 41250-950-02; NDC Rite Aid: 11822-0950-0; NDC Shopko: 37012-950-62; NDC Signature Care: 21130-568-62; NDC Topcare: 36800-950-62; NDC Walgreens: 0363-0950-02 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1018-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 tablets per bottle. [Brand, NDC] NDC Being Well: 46994-852-62; NDC Care One 41520-392-02; NDC CVS Health: 59779-540-02; NDC DG Health: 55910-852-02; NDC Equaline: 41163-852-62; NDC Equate: 49035-608-02; NDC Exchange Select: 55301-852-02; NDC Family Wellness: 55319-852-02; NDC Good Neighbor Pharmacy: 46122-224-62; NDC Good Sense 0113-0852-62; NDC Harris Teeter: 69256-041-62; NDC Health Mart 49348-109-04; NDC Kroger 30142-600-02; NDC Major 0904-6716-24; NDC Meijer: 41250-852-02; NDC Publix: 56062-099-02; NDC Rite Aid 11822-0852-5; NDC Select 7: 10202-852-62; NDC Shop Rite 41190-852-62; NDC Shopko: 37012-852-62; NDC Signature Care: 21130-116-02; NDC Sound Body: 50594-852-02; NDC Sunmark: 62011-0282-1; NDC Topcare: 36800-852-02; NDC Up & Up: 11673-023-02; NDC Walgreens: 0363-0852-62 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| 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-1021-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per bottle. [Brand, NDC] NDC DG Health: 55910-852-71; NDC Good Neighbor Pharmacy: 46122-224-71; NDC Good Sense: 0113-0852-71; NDC Harris Teeter: 69256-041-71; NDC Kroger: 30142-600-71; NDC Major: 0904-6716-51; NDC Meijer: 41250-852-71; NDC Publix: 56062-099-71; NDC Rite Aid: 11822-0852-2; NDC Signature Care: 21130-116-71; NDC Topcare: 36800-852-71 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1022-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per bottle. [Brand, NDC] NDC Care One: 41520-392-09; NDC CVS Health: 59779-540-09; NDC Family Wellness: 55319-852-09; NDC Good Neighbor Pharmacy: 46122-532-09; NDC HEB: 37808-507-09; NDC Health Mart: 49348-109-54; NDC Meijer: 41250-891-09; NDC Rite Aid: 11822-0852-3; NDC Shopko: 37012-852-09; NDC Sound Body: 50594-852-09; NDC Sunmark: 49348-109-54; NDC Up & Up: 11673-852-09; NDC Walgreens: 0363-0852-09 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1025-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-800-75; NDC Up & Up: 11673-950-75 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1020-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 tablets per bottle. [Brand, NDC] NDC Up & Up: 11673-950-58 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1024-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per bottle. [Brand, NDC] NDC Equate: 49035-608-75; NDC Up & Up: 11673-023-75 | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Perrigo Company PLC / | Class II | Terminated |
| D-1028-2020 | 10-23-2019 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets per bottle. [Brand, NDC] NDC Basic Care: 0113-7852-82; NDC CVS Health: 59779-540-82; NDC HEB: 37808-507-82; NDC Signature Care: 21130-116-82; NDC Walgreens: 0363-0852-82 | 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
