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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
| 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-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-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-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-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 Package NDCs: 42806-087-01; 42806-087-05; 42806-088-01; 42806-088-05; 42806-089-09; 42806-089-01; 42806-089-05 | 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
