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-0298-2020 | 09-27-2019 | Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-8 Package NDCs: 51672-1385-8; 51672-1385-9 | 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. / 138,886 bottles | Class II | Terminated |
| D-0299-2020 | 09-27-2019 | Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-1385-9 Package NDCs: 51672-1385-8; 51672-1385-9 | 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. / 639,325 bottles | Class II | Terminated |
| D-0300-2020 | 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: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, NDC 51672-2130-8 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. / 182,986 bottles | Class II | Terminated |
| D-0135-2020 | 09-26-2019 | Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic Pharma, LLC Laurelton, NY 11413, NDC 42806-087-01 | Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol 0.5 mg Tablets. | Epic Pharma, LLC / 11,472 (bottles of 100) | Class II | Terminated |
| D-0119-2020 | 09-26-2019 | Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 mg of Vivitrol, 2) One vial containing 4 mL of diluent, 3) One 5-mL prepackaged syringe, 4) One 20-gauge 1-inch needle, 5) Two 20-gauge 1.5-inch safety needles, 6) Two 20-gauge 2-inch safety needles. Rx Only. Manufactured and marketed by: Alkermes, Inc. Kit NDC: 65757-300-01 Package NDCs: 65757-300-01; 65757-302-02; 65757-304-03; 65757-301-01; 65757-303-02; 65757-305-03 | Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted. | Alkermes, Inc. / 16,231 kits | Class II | Terminated |
| D-0134-2020 | 09-24-2019 | Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ NDC 65162-754-10 Package NDCs: 65162-751-03; 65162-751-10; 65162-751-50; 65162-752-03; 65162-752-10; 65162-752-50; 65162-753-03; 65162-753-10; 65162-753-50; 65162-754-03; 65162-754-10; 65162-754-50 | Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle | Amneal Pharmaceuticals, Inc. / 9,720 100 count bottles | Class III | Terminated |
| D-0315-2020 | 09-24-2019 | Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30 Tablets NDC 0363-1029-03 Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). | Apotex Inc. / 42,873 bottles | Class II | Completed |
| D-0316-2020 | 09-24-2019 | Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack NDC: 49035-100-07; b) Single Pack NDC: 49035-100-00 | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). | Apotex Inc. / 1,132,453 bottles | Class II | Completed |
| D-0317-2020 | 09-24-2019 | Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer 24 Tablets Sugar Free NDC 11822-6107-4 Distributed By: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011 | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). | Apotex Inc. / 31,968 bottles | Class II | Completed |
| D-0318-2020 | 09-24-2019 | Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06 Distributed By: Wal-Mart Stores, Inc. Bentonville, AR 72716 | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). | Apotex Inc. / 162,344 bottles | Class II | Completed |
| D-0319-2020 | 09-24-2019 | Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8 | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). | Apotex Inc. / 215,387 bottles | Class II | Completed |
| D-0314-2020 | 09-24-2019 | Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 a) 200 Tablets NDC 0363-1030-07; b) 24 Tablets NDC 0363-1030-02; c) 95 Tablets NDC 0363-1030-09; d) 65 Tablets NDC 0363-1030-06 | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). | Apotex Inc. / 259,647 bottles | Class II | Completed |
| D-0132-2020 | 09-23-2019 | DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measured Single-Use Vials 0.17 fl. oz. (5 mL) Each 3.4 fl. oz. (100 mL), Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321 UPC 370302489026 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 144 cartons | Class II | Terminated |
| D-0130-2020 | 09-23-2019 | Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053. NDC 60432-212-08 | Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14 | Morton Grove Pharmaceuticals, Inc. / 196,408 bottles | Class II | Terminated |
| D-0128-2020 | 09-23-2019 | Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05 | CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA). | Sandoz, Inc / 13,130 bottles | Class II | Terminated |
| D-0129-2020 | 09-23-2019 | Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31 | CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA). | Sandoz, Inc / 136,788 bottles | Class II | Terminated |
| D-0133-2020 | 09-23-2019 | DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials a) 0.5 mL Each (20 count) UPC 37030244608; b) 1.5 mL Each (20 count) UPC 370302446098, Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321 | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia. | Unipharma, Llc. / 456 cartons | Class II | Terminated |
| D-0140-2020 | 09-23-2019 | Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India NDC 33342-054-07 Package NDCs: 33342-054-07; 33342-054-10; 33342-054-15; 33342-054-12; 33342-055-07; 33342-055-10; 33342-055-15; 33342-055-12; 33342-056-07; 33342-056-10; 33342-056-15; 33342-056-12 | Superpotent | Macleods Pharma Usa Inc / 31,968 bottles | Class II | Terminated |
| D-0127-2020 | 09-23-2019 | Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60 | CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA). | Sandoz, Inc / 100,314 bottles | Class II | Terminated |
| D-0166-2020 | 09-23-2019 | Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79 | CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty. | AuroMedics Pharma LLC / 69696 bottles | Class III | Ongoing |
| D-1883-2019 | 09-20-2019 | Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15. | Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product. | Akorn, Inc. / 60,176 bottles | Class II | Terminated |
| D-0143-2020 | 09-19-2019 | Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, Mixed Salts of a single Entity Amphetamine Product), 20mg, 100-count bottle, RX Only, Distributed by: Aurobindo Pharma USA Inc., Dayton, NJ 08810, NDC 13107-073-01 Package NDCs: 13107-068-50; 13107-068-01; 13107-068-25; 13107-068-05; 13107-068-99; 13107-069-50; 13107-069-01; 13107-069-25; 13107-069-05; 13107-069-99; 13107-070-50; 13107-070-01; 13107-070-25; 13107-070-05; 13107-070-99; 13107-071-50; 13107-071-01; 13107-071-25; 13107-071-05; 13107-071-99; 13107-072-50; 13107-072-01; 13107-072-25; 13107-072-05; 13107-072-99; 13107-073-50; 13107-073-01; 13107-073-25; 13107-073-05; 13107-073-99; 13107-074-50; 13107-074-01; 13107-074-25; 13107-074-05; 13107-074-99 | Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for weight and thickness. | Aurobindo Pharma USA Inc. / 11,129 100-count bottles | Class II | Terminated |
| D-0122-2020 | 09-19-2019 | Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million. | Torrent Pharma Inc. / 39,432 bottles | Class II | Ongoing |
| D-0121-2020 | 09-19-2019 | Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million. | Torrent Pharma Inc. / 8,688 bottles | Class II | Ongoing |
| D-0124-2020 | 09-19-2019 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-118-90 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million. | Torrent Pharma Inc. / 8,688 bottles | Class II | Ongoing |
| D-0123-2020 | 09-19-2019 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-116-90 | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 9.82 parts per million. | Torrent Pharma Inc. / 17,088 bottles | Class II | Ongoing |
| D-0126-2020 | 09-18-2019 | Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA. NDC 0904-5894-30 | Microbial Contamination of Non-Sterile Product. | GCP Laboratories Inc / 31,392 30 mL bottles | Class II | Terminated |
| D-0152-2020 | 09-18-2019 | Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ 85085. NDC 42852-006-20 | Lack of sterility assurance. | Avella of Deer Valley, Inc. Store 38 / 808 droptainers | Class II | Terminated |
| D-1878-2019 | 09-17-2019 | Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30 | cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line. | Akorn, Inc. / 10,543 tubes | Class II | Terminated |
| D-0320-2020 | 09-16-2019 | Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (60 mL) bottle, Manufactured By: Zaphiredelcor Cia, LTDA. Pasaje Luis Tola 9A Y Calle Juan Campuzano, Sector Carcelen, Quito-Ecuador 170302 Distributed By: Fitoterapia USA Inc., 500 NW 141 Ave. 112 Pembroke Pines, FL 33028 | Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil. | FITOTERAPIA USA, INC / 9000 bottles | Class I | Terminated |
| D-0138-2020 | 09-13-2019 | Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefilled Syringe For Power Injection per carton, RFID Technology, Rx Only, Manufactured by: Liebel-Flarshelm Company, LLC., Raleigh, NC 27616; NDC 0019-1188-27. Package NDCs: 0019-1188-81; 0019-1188-27 | Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector. | GUERBET LLC / 3140 syringes | Class III | Terminated |
| D-0137-2020 | 09-13-2019 | Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, packaged in 1 - 100 mL Ultraject Prefilled Syringe For Power Injection per carton, RFID Technology, Rx Only, Manufactured by: Liebel-Flarshelm Company, LLC., Raleigh, NC 27616; NDC 0019-1323-00. Package NDCs: 0019-1333-06; 0019-1333-11; 0019-1333-16; 0019-1333-21; 0019-1333-75; 0019-1333-77; 0019-1333-91; 0019-1333-83; 0019-1333-81; 0019-1333-78; 0019-1333-52; 0019-1333-95; 0019-1333-90; 0019-1333-87; 0019-1333-55; 0019-1333-85; 0019-1333-00; 0019-1333-27; 0019-1323-06; 0019-1323-11; 0019-1323-16; 0019-1323-21; 0019-1323-73; 0019-1323-75; 0019-1323-77; 0019-1323-91; 0019-1323-83; 0019-1323-81; 0019-1323-70; 0019-1323-78; 0019-1323-52; 0019-1323-95; 0019-1323-90; 0019-1323-87; 0019-1323-55; 0019-1323-85; 0019-1323-00; 0019-1323-27; 0019-1323-02; 0019-1323-04; 0019-1332-06; 0019-1332-11; 0019-1332-16; 0019-1332-21; 0019-1332-75; 0019-1332-78; 0019-1332-91; 0019-1332-83; 0019-1332-90; 0019-1332-00 | Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector. | GUERBET LLC / 3860 syringes | Class II | Terminated |
| D-0037-2020 | 09-12-2019 | Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0204-02 | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing | Shire Human Genetic Therapies, Inc. / 15,075 | Class I | Terminated |
| D-0036-2020 | 09-12-2019 | Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0203-02 | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing | Shire Human Genetic Therapies, Inc. / 13,897 | Class I | Terminated |
| D-0038-2020 | 09-12-2019 | Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA 68875-0205-02 | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing | Shire Human Genetic Therapies, Inc. / 8,003 | Class I | Terminated |
| D-0035-2020 | 09-12-2019 | Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0202-02 | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing | Shire Human Genetic Therapies, Inc. / 1,556 | Class I | Terminated |
| D-0080-2020 | 09-12-2019 | NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.016 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487, NDC 3321678032 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 528 bags | Class II | Terminated |
| D-0057-2020 | 09-12-2019 | Human Chorionic Gonadotropin 20,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673977 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 1871 vials | Class II | Terminated |
| D-0082-2020 | 09-12-2019 | Norepinephrine added to 5% Dextrose (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678217 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 2760 bags | Class II | Terminated |
| D-0116-2020 | 09-12-2019 | Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer,Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676223 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 242 droptainers | Class II | Terminated |
| D-0117-2020 | 09-12-2019 | L-Asparaginase Lyophilized, 10,000 International Units/Vial, For IV / IM / SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674499 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / N/A | Class II | Terminated |
| D-0065-2020 | 09-12-2019 | Ketamine in 0.9% Sodium Chloride (PF) 50 mg/ 5mL (10 mg/mL) 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678093 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 11733 syringes | Class II | Terminated |
| D-0068-2020 | 09-12-2019 | LIDOcaine HCl 1% (PF) 50 mg/5 mL (10 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678424 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 2565 syringes | Class II | Terminated |
| D-0103-2020 | 09-12-2019 | SUCCinylcholine Chloride (PF), 100 mg / 5 mL (20 mg/mL), 5 mL Fill in a 6 mL Single Dose Syringe, For IV Use-Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678418 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 7905 syringes | Class II | Terminated |
| D-0104-2020 | 09-12-2019 | SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678417 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 1350 syringes | Class II | Terminated |
| D-0094-2020 | 09-12-2019 | Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injections-CART-Item#: 73752, For SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 218 cartridges | Class II | Terminated |
| D-0072-2020 | 09-12-2019 | Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxine HCl 1,500 mg / Cyanocobalamin 30 mg Lyophilized, Vial For IM Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321675952 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 497 vials | Class II | Terminated |
| D-0108-2020 | 09-12-2019 | Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL) / Ketorolac Tromethamine 0.5% (5 mg/mL), 3 mL Droptainer, Sterile Ophthalmic Topical Solution, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676225 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 649 droptainers | Class II | Terminated |
| D-0046-2020 | 09-12-2019 | ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL (10 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe. KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678375 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 3895 syringes | Class II | Terminated |
| D-0107-2020 | 09-12-2019 | Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropicamide 1% (10 mg/mL), Sterile Ophthalmic Topical Solution, 5 mL Fill in a 7 mL Droptainer, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678092 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 242 droptainers | Class II | Terminated |
| D-0141-2020 | 09-12-2019 | Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG. CORP., Gardena, CA 90248 NDC 49452-0032-06 | CGMP Deviations: Received notice from supplier that there is potential glass contamination. | Spectrum Laboratory Products / 29.1 grams | Class II | Terminated |
| D-0073-2020 | 09-12-2019 | Methylcobalamin 30 mL Vial-For SC / IM / IV Use, 30 mg / 30 mL (1 mg / mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674232 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 1189 vials | Class II | Terminated |
| D-0086-2020 | 09-12-2019 | PHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL (0.1 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe Injection, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677379 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 15260 syringes | Class II | Terminated |
| D-0056-2020 | 09-12-2019 | Human Chorionic Gonadotropin 11,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673974 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 6620 vials | Class II | Terminated |
| D-0074-2020 | 09-12-2019 | Magnesium Chloride Hexahydrate 82.5 mg/mL; Calcium Gluconate 30 mg/mL (PF), For IV Use, 10 mL Single Dose vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678355 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 878 vials | Class II | Terminated |
| D-0062-2020 | 09-12-2019 | Hydroxocobalamin 10 mg/20 mL (0.5 mg/mL) 20 mL fill in a 30 mL Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678337 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 345 vials | Class II | Terminated |
| D-0044-2020 | 09-12-2019 | L-Carnitine 27 mL in a 30 mL Vial, 4,590 mg/27 mL (170 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674166 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 10014 vials | Class II | Terminated |
| D-0091-2020 | 09-12-2019 | Quadmix #13A (Prostaglandin E1-0.3 mg / Papaverine HCl-200 mg / Phentolamine Mesylate-30 mg / Atropine Sulfate Monohydrate-0.375 mg / Vial) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678398 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 91 vials | Class II | Terminated |
| D-0115-2020 | 09-12-2019 | Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL (PF), For IV Use, 3 mL fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678335 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 948 vials | Class II | Terminated |
| D-0083-2020 | 09-12-2019 | OxyTOCIN in 0.9% Sodium Chloride Solution (PF), 30 Units / 500 mL (0.06 Units / mL) Single Dose IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676819 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 4497 bags | Class II | Terminated |
| D-0084-2020 | 09-12-2019 | Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678441 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 825 syringe | Class II | Terminated |
| D-0101-2020 | 09-12-2019 | Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL), 50 mL Fill in a 60 mL Single Dose Syringe, For IV Use, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674199 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 540 syringes | Class II | Terminated |
| D-0048-2020 | 09-12-2019 | ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 50 mg/10 mL (5 mg/mL) 10 mL Fill in a 12 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678373 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 16585 syringes | Class II | Terminated |
| D-0118-2020 | 09-12-2019 | Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Single Dose Only, Contains Sulfites, For Slow IV use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677610 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / N/A | Class II | Terminated |
| D-0077-2020 | 09-12-2019 | NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677847 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 7685 syringes | Class II | Terminated |
| D-0112-2020 | 09-12-2019 | Vitamin 5 B, 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674253 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 616 vials | Class II | Terminated |
| D-0049-2020 | 09-12-2019 | fentaNYL Citrate in 0.9% Sodium Chloride (PF) 1,000 mcg/100 mL (10 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216282300 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 492 bags | Class II | Terminated |
| D-0089-2020 | 09-12-2019 | PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites). 30 mg/250 mL (0.12 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678401 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 60 bags | Class II | Terminated |
| D-0054-2020 | 09-12-2019 | GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC3321678316 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 10630 syringes | Class II | Terminated |
| D-0070-2020 | 09-12-2019 | Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL (PF) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678368 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 2615 syringes | Class II | Terminated |
| D-0102-2020 | 09-12-2019 | Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Catheter Use Only, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676603 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 150 vials | Class II | Terminated |
| D-0069-2020 | 09-12-2019 | LIDOcaine HCl 2% (PF) 100 mg/5 mL (20 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487NDC 3321678315 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 4450 syringes | Class II | Terminated |
| D-0105-2020 | 09-12-2019 | SUCCinylcholine Chloride (PF), 200 mg/10 mL (20 mg/mL), 10 mL Fill in a 12 mL Single Dose Syringe, For IV Use Injection, Rx Only KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678416 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 3820 syringes | Class II | Terminated |
| D-0067-2020 | 09-12-2019 | LIDOcaine HCl 0.75%(7.5 mg/mL)/ EPINRPHrine 0.025% (0.25 mg/mL) (PF) (Sulfite Free) in BSS, 1 mL Fill in a 3 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678395 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 4105 syringes | Class II | Terminated |
| D-0064-2020 | 09-12-2019 | Ketamine in 0.9% Sodium Chloride (PF) 10 mg/mL, 1 mL fill in a 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216077967 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 1044 syringes | Class II | Terminated |
| D-0085-2020 | 09-12-2019 | PHENYLephrine HCl 1.5% (15 mg/mL) LIDOcaine 1% (10 mg/mL) (PF) (Sulfite Free) Ophthalmic Injection, 3 mL fill in a 5 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678170 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 3150 vials | Class II | Terminated |
| D-0040-2020 | 09-12-2019 | Ascorbic Acid (Tapioca Source) (PF) 25 g/50 mL (0.5 g/mL) 50 mL Vial-Single Dose Only-For IV/SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487 NDC 3321675412 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 2219 vials | Class II | Terminated |
| D-0109-2020 | 09-12-2019 | Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL), 0.5 mL Fill in a 3 mL Syringe, Sterile Ophthalmic Topical Solution, (Contains Sulfites), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677124 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 465 syringes | Class II | Terminated |
| D-0066-2020 | 09-12-2019 | Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Syringe, Rx only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676419 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 6405 syringes | Class II | Terminated |
| D-0087-2020 | 09-12-2019 | PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 250 mL (0.4 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678039 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 228 bags | Class II | Terminated |
| D-0060-2020 | 09-12-2019 | Hyaluronidase (PF) Ophthalmic Injection 450 Units/3 mL (150 Units/mL) 3 mL Fill in a 5 mL Single Dose Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678359 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 928 vials | Class II | Terminated |
| D-0075-2020 | 09-12-2019 | Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.25 mg / 0.25 mL, 0.25 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678126 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 1290 syringes | Class II | Terminated |
| D-0088-2020 | 09-12-2019 | PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 25 mg / 250 mL (0.1 mg/mL), 250 mL Single-Dose Bag For IV Infusion Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677861 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 708 bags | Class II | Terminated |
| D-0114-2020 | 09-12-2019 | Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678339 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 6325 vials | Class II | Terminated |
| D-0045-2020 | 09-12-2019 | L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL (75 mg/mL) Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321676396 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 6447 vials | Class II | Terminated |
| D-0092-2020 | 09-12-2019 | Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine Mesylate-15 mg / Atropine Sulfate Monohydrate-1.5 mg/vial), Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678383 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 95 vials | Class II | Terminated |
| D-0106-2020 | 09-12-2019 | Cyclopentolate HCl 1% (5 mg/0.5 mL) / Phenylephrine HCl 2.5% (12.5 mg/0.5 mL) / Tropicamide 1% (5 mg/0.5 mL) / Ketorolac Tromethamine 0.5% (2.5 mg/0.5 mL), Sterile Ophthalmic Topical Solution, 0.5 mL Fill in 3 mL Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321677510 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 1815 syringes | Class II | Terminated |
| D-0055-2020 | 09-12-2019 | GLYCOpyrrolate (PF) 1 mg/5 mL (0.2 mg/mL) 5 mL Fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC03321678317 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 2625 syringes | Class II | Terminated |
| D-0076-2020 | 09-12-2019 | Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 mL Fill in a 1 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678320 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 9920 syringes | Class II | Terminated |
| D-0099-2020 | 09-12-2019 | Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673588 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 341 vials | Class II | Terminated |
| D-0078-2020 | 09-12-2019 | NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678303 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 3410 syringes | Class II | Terminated |
| D-0100-2020 | 09-12-2019 | Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674092 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 120 vials | Class II | Terminated |
| D-0081-2020 | 09-12-2019 | NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 8 mg/250 mL (0.032 mg/mL),Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678406 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 1464 bags | Class II | Terminated |
| D-0058-2020 | 09-12-2019 | Human Chorionic Gonadotropin 5,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC03321673964 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 2219 vials | Class II | Terminated |
| D-0047-2020 | 09-12-2019 | ePHEDrine Sulfate in 0.9% Sodium Chloride (PF) 25 mg/5 mL (5 mg/mL) 5 mL Fill in a 6 mL Syringe, Single Dose Syringe, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678374 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 12445 syringes | Class II | Terminated |
| D-0061-2020 | 09-12-2019 | Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678336 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 1528 | Class II | Terminated |
| D-0059-2020 | 09-12-2019 | Human Chorionic Gonadotropin 6,000 Units/Vials Lyophilized For SC/IM Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321673969 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 2263 vials | Class II | Terminated |
| D-0093-2020 | 09-12-2019 | Sermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321674047 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 258 vials | Class II | Terminated |
| D-0050-2020 | 09-12-2019 | fentaNYL Citrate in 0.9% Sodium Chloride (PF), 2,000 mcg/100 mL (20 mcg/mL) 100 mL Fill in 150 mL IV Bag, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 33216286300 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 934 bags | Class II | Terminated |
| D-0079-2020 | 09-12-2019 | Nicotinamide Adenine Dinucleotide (PF), Lyophilized-For IV Use-Single Dose Vial, 500 mg/Vial, Rx Only, KRS Global Biotechnology 791 Park of Commerce Blvd, Boca Raton, FL 33487. NDC 3321678103 | Lack of Assurance of Sterility | KRS Global Biotechnology, Inc / 4390 vials | Class II | Terminated |
