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-0702-2021 | 07-30-2021 | Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For IV Use only, BayCare Central Pharmacy, 7802 E. Telecom Parkway, Temple Terrace, FL 33837 | Lack of sterility assurance | BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy / 253 syringes | Class II | Terminated |
| D-0732-2021 | 07-29-2021 | Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vials (NDC 0703-7131-01), b) 5 mL multi-dose vials (NDC 0703-7133-01), Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 16,226 vials | Class II | Terminated |
| D-0721-2021 | 07-29-2021 | Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605 Package NDCs: 0121-0868-02; 0121-0868-16; 0121-0868-05; 0121-0868-40; 0121-0868-50; 0121-0868-00 | Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. | PAI Holdings, LLC. dba Pharmaceutical Associates Inc / a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case) | Class II | Terminated |
| D-0741-2021 | 07-29-2021 | Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-4502-01 Package NDCs: 0703-4502-01; 0703-4502-04 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 25,653 vials | Class II | Terminated |
| D-0723-2021 | 07-29-2021 | Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16 Package NDCs: 0121-0670-16 | Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. | PAI Holdings, LLC. dba Pharmaceutical Associates Inc / 75 cases (6 bottles/case) | Class II | Terminated |
| D-0726-2021 | 07-29-2021 | GaviLyteTM - C PEG-3350 (240g) and Electrolytes for Oral Solution, USP with Flavor Pack Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, USA Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-060-19 Package NDCs: 43386-060-19 | Failed Stability Specification; Out of specification for Osmolarity | Novel Laboratories, Inc. d.b.a LUPIN / 20,814 bottles | Class II | Terminated |
| D-0806-2021 | 07-29-2021 | Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC 0904-6822-04 Package NDCs: 0904-6822-04; 0904-6822-07 | Failed Dissolution Specifications | The Harvard Drug Group / 1,632 cartons | Class II | Terminated |
| D-0703-2021 | 07-29-2021 | Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis, TN 38141 Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvari, Kabay Janos u.29.Hungary. Product of India NDC 16714-657-01 | Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg | SUN PHARMACEUTICAL INDUSTRIES INC / 2856 bottles | Class II | Terminated |
| D-0722-2021 | 07-29-2021 | Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0649-08 | Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. | PAI Holdings, LLC. dba Pharmaceutical Associates Inc / 400 cases (12 bottles/case) | Class II | Terminated |
| D-0776-2021 | 07-29-2021 | Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 57237-266-01 | CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate. | Teva Pharmaceuticals USA / 4,992 bottles | Class II | Terminated |
| D-0775-2021 | 07-29-2021 | Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, NDC 70199-014-01 | CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate. | Teva Pharmaceuticals USA / 4,587 bottles | Class II | Terminated |
| D-0769-2021 | 07-29-2021 | Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59 | Defective container: possibility for lack of seal integrity. | Teligent Pharma, Inc. / 7488 bottles | Class II | Ongoing |
| D-0739-2021 | 07-29-2021 | Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, vial NDC 0703-1153-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 34,100 vials | Class II | Terminated |
| D-0734-2021 | 07-29-2021 | Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-4156-11 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 2,091 vials | Class II | Terminated |
| D-0742-2021 | 07-29-2021 | Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single use vial per carton (NDC 0703-1501-02), Rx only, Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054, Vial NDC 0703-1501-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 2,199 vials | Class II | Terminated |
| D-0733-2021 | 07-29-2021 | Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials, Rx only, Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0703-9040-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 4,712 vials | Class II | Terminated |
| D-0740-2021 | 07-29-2021 | Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx only, Manufactured by: Teva Pharmaceuticals USA Inc. Parsippany, NJ 07054, NDC 0703-8776-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 4,249 vials | Class II | Terminated |
| D-0730-2021 | 07-29-2021 | DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in 1 carton, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618 Vial NDC# 0703-5233-11, Carton NDC # 0703-5233-13 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 1,351 vials | Class II | Terminated |
| D-0747-2021 | 07-29-2021 | Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-5145-91 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 42,046 vials | Class II | Terminated |
| D-0744-2021 | 07-29-2021 | Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3311-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 3,067 vials | Class II | Terminated |
| D-0746-2021 | 07-29-2021 | Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 476,275 vials | Class II | Terminated |
| D-0745-2021 | 07-29-2021 | Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3301-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 6,184 vials | Class II | Terminated |
| D-0735-2021 | 07-29-2021 | Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceuticals USA, North Wales, PA 19454, NDC 0703-2914-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 62,358 vials | Class II | Terminated |
| D-0743-2021 | 07-29-2021 | Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0051-01), and b) 5mL Multi Dose Vials (NDC 0703-0063-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 50,713 vials | Class II | Terminated |
| D-0736-2021 | 07-29-2021 | Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 16,644 vials | Class II | Terminated |
| D-0748-2021 | 07-29-2021 | Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 20,800 vials | Class II | Terminated |
| D-0738-2021 | 07-29-2021 | Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0703-1995-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 12,698 vials | Class II | Terminated |
| D-0737-2021 | 07-29-2021 | Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01 | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 434,229 vials | Class II | Terminated |
| D-0785-2021 | 07-29-2021 | Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-14. | Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing. | Teligent Pharma, Inc. / 114,456 tubes | Class III | Terminated |
| D-0731-2021 | 07-29-2021 | Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a) 1 mL Single-Dose vials (0703-0031-01), and b) 5mL Multi Dose Vials (NDC 0703-0043-01), and c) 10 mL Multi-Dose Vials (NDC 0703-0045-01), Rx only, TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454. | Lack of Assurance of Sterility | Teva Pharmaceuticals USA / 193,845 vials | Class II | Terminated |
| D-0774-2021 | 07-29-2021 | Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3330-01 | CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate. | Teva Pharmaceuticals USA / 9,655 bottles | Class II | Terminated |
| D-0352-2022 | 07-27-2021 | Wal-Fex Fexofenadine Hydrochloride tablets, 180mg/antihistamine, 24HR, packaged as a) 5 count bottle, NDC 0363-0600-13,UPC 3 11917 12267 0, b)30 count bottle, NDC 0363-0600-39 UPC 3 11917 16172 3 c) 90 count bottle, NDC 0363-0600-75 UPC 3 11917 12271 7 ; Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015, Made in the Czech Republic, | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 14,160 containers | Class II | Terminated |
| D-0350-2022 | 07-27-2021 | TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 5 count bottle, NDC 36800-319-13 UPC 0 36800 33277-5 b) 15 count bottle, NDC 36800-319-22 UPC 0 36800 33278 2; c) 45 count bottle, NDC 36800-319-95 UPC 0 36800 33280-5; d) 90 count bottle, NDC 36800-319-75 UPC 0 36800 33282 9; Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic, | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 13,656 containers | Class II | Terminated |
| D-0333-2022 | 07-27-2021 | berkley jensen, ALLERGY RELIEF, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 150 count bottle, Made in the Czech Republic, Distributed by: BJ's WHolesale Club 25 Research Drive Westborough, MA 01581 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 7,670 containers | Class II | Terminated |
| D-0342-2022 | 07-27-2021 | MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Distributed by Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. Made in the Czech Republic, NDC 0904-6979-60 UPC 3 09046 97960 9 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 65,796 containers | Class II | Terminated |
| D-0336-2022 | 07-27-2021 | DG/health Aller.Ease, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 10 count bottle, Distributed by: Made in Czech Republic. Distributed by Dolgencorp, LLC, 100 Mission Ridge Goodlettsville, TN 37072. UPC 3 70030 65779 7 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 24,912 containers | Class II | Terminated |
| D-0345-2022 | 07-27-2021 | Perrigo Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-571-78 UPC 3 45802 571 78 6 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 89,664 containers | Class II | Terminated |
| D-0354-2022 | 07-27-2021 | amazon basic+care, Allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Amazon.com services LLC 410 Terry Avenue N., Seattle WA 98109, NDC 72288-425-78 UPC 3 70030 14536 2 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 38,352 bottles | Class II | Terminated |
| D-0329-2022 | 07-27-2021 | GoodSense Aller.Ease, Fexofenadine hydrochloride 12 HR, 60 mg tablets, 24 count bottle, UPC 3 0113 0425 62 7; Made in the Czech Republic, Distributed by: Perrigo Allergan MI 49010. | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 36,048 containers | Class II | Terminated |
| D-0349-2022 | 07-27-2021 | TopCare Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed Topco Associates LC, Elk Grove Village, IL 60007, Made in the Czech Republic, NDC 36800-954-53 UPC 0 36800 33284 3 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 26,304 containers | Class II | Terminated |
| D-0330-2022 | 07-27-2021 | amazon, Allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 30 count bottle, Made in the Czech Republic, Distributed by: Amazon.com Services LLC 410 Terry Avenue N. Seattle, WA 98109 UPC 3 70030 11466 5 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 32,232 containers | Class II | Terminated |
| D-0353-2022 | 07-27-2021 | Wal-Fex Fexofenadine Hydrochloride tablets, 60mg/antihistamine, 12HR, 24 count bottle, Distributed by Walgreen Co. 200 Wilmot Rd Deerfield IL 60015, Made in the Czech Republic, NDC 0363-0903-62 UPC 3 11917 18625 2 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 4,536 containers | Class II | Terminated |
| D-0355-2022 | 07-27-2021 | KIRKLAND ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24HR, 180 count bottle, Made in the Czech Republic, Packaged by Perrigo 515 Eastern Ave., Allegan, MI 49010, For Costco Wholesale Corporation. P.O. Box 34535 Seattle, WA 98124-1535, NDC 63981-571-48, UPC 0 96619 98776 4 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 42,026 containers | Class II | Terminated |
| D-0343-2022 | 07-27-2021 | Meijer allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, NDC 41250-060-22 UPC 7 60236 18716 5; b) 30 count bottle, NDC 41250-060-39, UPC 7 60236 18717 2; c) 45 count bottle, NDC 41250-060-95, UPC 7 60236 18732 5; Made in the Czech Republic, Distributed by Meijer Distribution Inc, Grand Rapids, MI 49544. | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 4536 containers | Class II | Terminated |
| D-0332-2022 | 07-27-2021 | basic+care, allergy Fexofenadine Hydrochloride Tablets, 60 mg/Antihistamine, 12HR, 100 count bottle, Made in the Czech Republic, Distributed by: Perrigo Allergan, MI 49010, NDC 0113-7425-78 UPC 3 70030 14536 2 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 62,568 containers | Class II | Terminated |
| D-0357-2022 | 07-27-2021 | GoodSense Aller.Ease, Fexofenadine hydrochloride 24 HR, 180 mg tablets, 30 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan MI., 49010, UPC 3 0113 0571 39 3; NDC 0113-0571-30, | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 3,168 bottles | Class II | Terminated |
| D-0346-2022 | 07-27-2021 | Perrigo Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 count bottle, Made in the Czech Republic, Distributed by Perrigo Allergan, MI 49010 NDC 45802-425-78 UPC 3 45802 425 78 2 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 41,472 containers | Class II | Terminated |
| D-0351-2022 | 07-27-2021 | up&up allergy relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/antihistamine, packaged as a) 15 count bottle, NDC 11673-571-22 UPC 3 70030 62303 7; b) 30 count bottle, NDC 11673-571-39 UPC 3 70030 62301 3; Distributed by Target Corp., Mpls., MN 55403, Made in the Czech Republic, | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 7,272 containers | Class II | Terminated |
| D-0341-2022 | 07-27-2021 | Kroger Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 12 count bottle, Distributed by the Kroger CO. Cincinnati, Ohio 45202. Made in the Czech Republic, NDC 30142-555-53 UPC 0 41260 35588 2 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 48,816 containers | Class II | Terminated |
| D-0356-2022 | 07-27-2021 | CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, 30 count bottle, NDC 69842-698-39, UPC 0 50428 62564 4 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 2,784 bottles | Class II | Terminated |
| D-0334-2022 | 07-27-2021 | CAREONE Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine, 24HR, packaged as a)30 count bottle, NDC 41520-229-39, UPC 3 41520 31984 6; b)45 count bottle, NDC 41520-229-95 UPC 3 41520 31983 9; Made in the Czech Republic, Distributed by: Foodhold U.S.A. LLC Landover, MD 20785. Made in Czech Republic Package NDCs: 41520-229-95; 41520-229-39; 41520-229-22 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 28776 containers | Class II | Terminated |
| D-0328-2022 | 07-27-2021 | EQUALINE aller-ease fexofenadine hydrochloride tablets, 180 mg, 24 HR, packaged as a) 15 count bottle, NDC 41163-571-22, UPC 0 41163 48067 4; b) 70 tablets per bottle, NDC 41163-571-01, UPC 0 41163 49847 1; Made in the Czech Republic, Distributed by: UNFI Providence, RI 02908. | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 55,032 units | Class II | Terminated |
| D-0331-2022 | 07-27-2021 | basic+care, allergy Fexofenadine Hydrochloride Tablets, 180 mg/Antihistamine, 24 HR, 150 count bottle, Made in the Czech Republic, Distributed by: Perrigo Allergan, MI 49010, NDC 0113-7571-47 UPC 3 70030 11470 2 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 28,320 containers | Class II | Terminated |
| D-0337-2022 | 07-27-2021 | Health Mart, Fexofenadine Hydrochloride tablets, 12HR, 60mg . Antihistamine 12 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0413-1, UPC 0 52569 14278 3 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 12,384 containers | Class II | Terminated |
| D-0338-2022 | 07-27-2021 | Health Mart, Fexofenadine Hydrochloride tablets, 24HR, 180mg . Antihistamine 70 count bottle, Distributed by: Mckesson 6555 State Highway 161, Irvine, TX 75039. Made in the Czech Republic, NDC 62011-0233-1, UPC 0 52569 13787 1 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 6,960 containers | Class II | Terminated |
| D-0340-2022 | 07-27-2021 | H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 24HR, 180mg/Antihistamine packaged as a) 15 count bottle, NDC 37808-571-22, UPC 0 41220 53081 6; b) 30 count bottle, NDC 37808-571-39, UPC 0 41220 53082 3; c) 45 count bottle, NDC 37808-571-95, UPC 0 41220 53083 0; Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 13,920 containers | Class II | Terminated |
| D-0339-2022 | 07-27-2021 | H.E.B Allergy Relief, Fexofenadine Hydrochloride tablets, 12HR, 60mg/Antihistamine 12 count bottle, Made with Pride & Care for H.E.B. San Antonio TX 78204, Product of Czech Republic, NDC 37808-425-53, UPC 0 41220 53080 9 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 26,304 containers | Class II | Terminated |
| D-0347-2022 | 07-27-2021 | Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 24 count bottle, Made in the Czech Republic, Distributed by Rite Aid 30 Hunter Lane Camp Hill PA 17011 NDC 11822-0425-0 UPC 0 11822 85410 8 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 79,776 containers | Class II | Terminated |
| D-0335-2022 | 07-27-2021 | CVS Allergy Relief, Fexofenadine Hydrochloride Tablets, 60 mg Antihistamine, 12HR, packaged as a) 12 count bottle, NDC 59779-425-53, UPC 0 50428 25414 1; b)24 count bottle, NDC 59779-425-62, UPC 0 50428 53435 9; Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, Made in Czech Republic | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 138,144 containers | Class II | Terminated |
| D-0344-2022 | 07-27-2021 | allergyrelief, Fexofenadine Hydrochloride tablets, 24HR, 1800mg Antihistamine, packaged as a) 15 count bottle, NDC 56062-571-22 UPC 0 41415 38973 1; b) 45 count bottle, NDC 56062-571-95 UPC 0 41415 38773 7; Distributed by PubliX SUpermarket Inc 3300 Publix Corporate Parkway Lakeland, FL 33811, Made in the Czech Republic | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 2280 containers | Class II | Terminated |
| D-0348-2022 | 07-27-2021 | Rite Aid ALLERGY RELIEF Fexofenadine Hydrochloride tablets, 24HR, 180mg Antihistamine, packaged as a) 30 count bottle, NDC 11822-0571-2 UPC 0 11822 99908 3; b) 150 count bottle, NDC 11822-0571-5 UPC 0 11822 85411 5; Made in the Czech Republic, Distributed by Rite Aid 30 Hunter Lane Camp Hill PA 17011 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 44,688 containers | Class II | Terminated |
| D-0727-2021 | 07-26-2021 | Cholestene capsules, 1200 mg of red yeast rice per 2 capsules, 120-count bottle, Manufactured by: High Performance Formulas, L.L.C. (HPF, L.L.C.) P.O. Box 1311, Morrisville, PA 19067, UPC 640485-10093-4 | Marketed Without an Approved NDA/ANDA | High Performance Formulas, L.L.C. (HPF, L.L.C.) / 14,848 bottles | Class II | Terminated |
| D-0762-2021 | 07-23-2021 | PDI Povidone-Iodine Cleansing Scrub Swabstick (1's), 1 Swabstick, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S48050, NDC 10819-3891-2, UPC (01)00310819000192. | SubPotent: Out of Specification | Professional Disposables International, Inc / 5,477 cases | Class II | Terminated |
| D-0763-2021 | 07-23-2021 | PDI Povidone-Iodide Cleansing Scrub Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376, Reorder No S82125, NDC 10819-3891-3, UPC (01)00310819000208. | SubPotent: Out of Specification | Professional Disposables International, Inc / 3,113 cases | Class II | Terminated |
| D-0764-2021 | 07-23-2021 | PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick, (1's), Step 1, packaged as a) Step 1 Scrub, 1 Swabstick, NDC 10819-3891-1, b) Step 2 Prep, 1 Swabstick, NDC 10819-3890-1, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S23125, UPC (01)00318019000161 | SubPotent: Out of Specification | Professional Disposables International, Inc / 11,039 cases | Class II | Terminated |
| D-0758-2021 | 07-23-2021 | PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in (5.1x6.4 cm)], Professional Disposables International Inc., Orangeburg, NY 10962-1376 Reorder No. B40600; UPC (01)00310819000147, NDC 10819-3883-1, Package NDCs: 10819-3883-1; 10819-3883-3; 10819-3885-1; 10819-3885-2; 0031081900 | SubPotent: Out of Specification | Professional Disposables International, Inc / 53588 cases | Class II | Terminated |
| D-0760-2021 | 07-23-2021 | PDI Povidine Iodine Swabstick (1's), 1 swabstick, Professional Disposable International, Inc. Orangeburg, NY 10962 -1376 Reorder No S41350 NDC 10819-3885-1, UPC (01)00310819000178. Package NDCs: 10819-3883-1; 10819-3883-3; 10819-3885-1; 10819-3885-2; 0031081900 | SubPotent: Out of Specification | Professional Disposables International, Inc / 41,105 cases | Class II | Terminated |
| D-0761-2021 | 07-23-2021 | PDI Povidone-Iodine Swabstick (3's), 3 Swabsticks, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 Reorder No S41125 NDC 10819-3885-2, UPC (01)00310819000185 Package NDCs: 10819-3883-1; 10819-3883-3; 10819-3885-1; 10819-3885-2; 0031081900 | SubPotent: Out of Specification | Professional Disposables International, Inc / 51,926 cases | Class II | Terminated |
| D-0759-2021 | 07-23-2021 | PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International, Inc., Orangeburg, NY 10962 -1376 USA Reorder No C12400 NDC 10819-3883-3, UPC (01)00310819000154 Package NDCs: 10819-3883-1; 10819-3883-3; 10819-3885-1; 10819-3885-2; 0031081900 | SubPotent: Out of Specification | Professional Disposables International, Inc / 1982 cases | Class II | Terminated |
| D-0770-2021 | 07-20-2021 | Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030 | Marketed without ANDA/NDA approval | HIS ENTERPRISE INC / N/A | Class II | Ongoing |
| D-0751-2021 | 07-19-2021 | Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-022-85 ; packaged in tubes. | Correct Labeled Product Mispack | Teligent Pharma, Inc. / 14688 tubes | Class II | Terminated |
| D-0752-2021 | 07-19-2021 | Triamcinolone Acetonide Ointment USP, 0.1% 80 g cartons, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-014-80 ; packaged in tubes. | Correct Labeled Product Mispack | Teligent Pharma, Inc. / N/A | Class II | Terminated |
| D-0750-2021 | 07-19-2021 | Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 INDIA, NDC 55111-180-15. Package NDCs: 55111-179-30; 55111-179-15; 55111-179-03; 55111-179-10; 55111-180-30; 55111-180-15; 55111-180-03; 55111-180-10 | Failed Tablet/Capsule Specification: Some tablets are shaved | Dr. Reddy's Laboratories, Inc. / 37560 bottles | Class II | Terminated |
| D-0001-2022 | 07-16-2021 | ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton) | Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil | Alpha-Tek LLC / Unknown | Class I | Ongoing |
| D-0696-2021 | 07-15-2021 | Azelaic Acid 99.0+% Micro 500 Grams, Distributed By: A.P.I. Solutions Daphne Alabama Manufactured by: Yicheng Chemicals Corp. China Distributed by: Syntec Pharma Corp New York | cGMP Deviations | API Solutions Inc. / 1 bottle | Class II | Terminated |
| D-0695-2021 | 07-15-2021 | Estriol USP41 Micro 25 Grams, Distributed by: A.P.I. Solutions 25309 Friendship Rd Daphne, AL Distributed by: Syntec Pharma Corp., NY MFT by: Wuhan Fortune Chemical Co., Ltd., China, NDC: 46144-300-01 | cGMP Deviations | API Solutions Inc. / 20 bottles | Class II | Terminated |
| D-0834-2021 | 07-14-2021 | Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10036 2 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 867,816 cans | Class II | Ongoing |
| D-0848-2021 | 07-14-2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858 UPC 0 86800 10048 5 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 411,180 cans | Class II | Ongoing |
| D-0838-2021 | 07-14-2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10040 9 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 2,724,480 cans | Class II | Ongoing |
| D-0833-2021 | 07-14-2021 | Neutrogena Beach Defense water + sun protection sunscreen spray BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), a) NET WT. 6.5 OZ (184 g) (UPC 0 86800 87273 3) and b) NET WT. 8.5 oz (240 g) (UPC 0 86800 10032 4) aerosol can, Distributed by JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / a) 1,265,724 b) 1,052,544cans | Class II | Ongoing |
| D-0841-2021 | 07-14-2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (6%), NET WT. 6.5 OZ (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10144 4 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 876,960 cans | Class II | Ongoing |
| D-0839-2021 | 07-14-2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 100+, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (15%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08858, UPC 0 86800 10041 6 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 3,985,392 cans | Class II | Ongoing |
| D-0849-2021 | 07-14-2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 6.5 OZ. (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11254 9 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / N/A | Class II | Ongoing |
| D-0844-2021 | 07-14-2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 50, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 6.5 OZ. (184 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11254 9 | Chemical Contamination: presence of benzene | Johnson & Johnson Consumer, Inc. / 1,437,804 cans | Class I | Ongoing |
| D-0840-2021 | 07-14-2021 | Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 100, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), Oxybenzone (6%) aerosol can, NET WT. 5.0 OZ (141 g) Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 10143 7 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 405,264 cans | Class II | Ongoing |
| D-0837-2021 | 07-14-2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 45, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), a) Net Wt. 5 OZ (141 g) (UPC 0 86800 10039 3) and b) Net Wt. 8.0 oz. (226 g) (UPC 0 86800 11134 4) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ, 08858, | cGMP Deviations | Johnson & Johnson Consumer, Inc. / a) 5oz-1,282,488; b) 8oz-475,476 cans | Class II | Ongoing |
| D-0846-2021 | 07-14-2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), a) NET WT. 6.5 OZ. (184 g) (UPC 0 86800 87274 0) and b) NET WT. 8.5 OZ. (240 g) (UPC 0 86800 10048 5) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / a) 3,672,204; b) 11,180 cans | Class II | Ongoing |
| D-0835-2021 | 07-14-2021 | Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 70, Avobenzone (3%), Homosalate (15%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858, UPC 0 86800 10037 9 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 678,384 cans | Class II | Ongoing |
| D-0843-2021 | 07-14-2021 | Neutrogena Invisible Daily defense body spray sunscreen BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 OZ. (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11154 2 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 88,380 cans | Class II | Ongoing |
| D-0832-2021 | 07-14-2021 | Neutrogena COOLDRY SPORT sunscreen spray SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), a) Net Wt 5.0 oz (141g) (UPC 0 86800 10035 5) and b) Net Wt. 8 oz. (226 g) UPC 0 86800 10031 7 aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER INC., Skillman, NJ 08858, | cGMP Deviations | Johnson & Johnson Consumer, Inc. / a) 223,884; b) 245,880 cans | Class II | Ongoing |
| D-0845-2021 | 07-14-2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%) NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11255 6 | Chemical Contamination: presence of benzene | Johnson & Johnson Consumer, Inc. / 387,648 cans | Class I | Ongoing |
| D-0836-2021 | 07-14-2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), Net Wt. 5.0 OZ (141 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858 UPC 0 86800 10038 6 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 1,611,180 cans | Class II | Ongoing |
| D-0847-2021 | 07-14-2021 | Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30, Avobenzone (3%), Homosalate (8%), Octisalate (5%), Octocrylene (8%), Net Wt. 8.0 oz. (226 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NY 08858 UPC 0 86800 11133 7 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 196,380 cans | Class II | Ongoing |
| D-0831-2021 | 07-14-2021 | Aveeno Protect + Refresh sunscreen weightless spray with oat SPF 60, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%), NET WT. 5.0 (OZ) (141 g) aerosol can, Distributed by: Johnson & Johnson Consumer Inc., Skillman, NJ 08558 UPC 3 8137-119462 9 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 134,280 cans | Class II | Ongoing |
| D-0842-2021 | 07-14-2021 | Neutrogena COOLDRY SPORT WITH MICROMESH SUNSCREEN SPRAY Broad Spectrum SPF 50, Avobenzone 2.7%, Homosalate 5%, Octisalate 4.5%, Octocrylene 6%, Oxybenzone 4.5%. NET WT. 5.5 OZ. (155 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11033 0 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / 1,448,520 cans | Class II | Ongoing |
| D-0850-2021 | 07-14-2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM SPF 60+, Avobenzone (3%), Homosalate (10%), Octisalate (5%), Octocrylene (10%) NET WT. 8.5 OZ. (240 g) aerosol can, Distributed by: JOHNSON & JOHNSON CONSUMER, INC. Skillman, NJ 08858, UPC 0 86800 11255 6 | cGMP Deviations | Johnson & Johnson Consumer, Inc. / N/A | Class II | Ongoing |
| D-0749-2021 | 07-14-2021 | Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 45.0G (15 tea sachets per box), Manufactured by Havyco No. 45, Group 1, National Highway 14, Son Hiep Hamlet, Tho Son Commune, Bu Dang District, Binh Phuoc Province, Vietnam, Website: trathaomocgiamcan.com. | Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine. | Qikmoov LLC / 591 boxes | Class I | Ongoing |
| D-0793-2021 | 07-12-2021 | QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun District, Guanzhou, China Distributed by Native Promotional Products, Tulsa, OK NDC 74447-010 | Subpotent | NATIVE PROMOTIONS, INC / 4,320 bottles | Class II | Terminated |
| D-0692-2021 | 07-09-2021 | Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910 | Lack of Assurance of Sterility | Innoveix Pharmaceuticals Inc / 728 vials | Class II | Completed |
| D-0693-2021 | 07-09-2021 | Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection, Rx Only, Compounded by: Innoveix Addison, TX 75001 800-370-1910 | Lack of Assurance of Sterility | Innoveix Pharmaceuticals Inc / 1,316 vials | Class II | Completed |
