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 July 25, 2025 and include a total of 16975 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| 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-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-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-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-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-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-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-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-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 Package NDCs: 11822-0425-0 | 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-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-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-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-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-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 Package NDCs: 56062-571-22; 56062-571-39; 56062-571-95 | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A during stability testing. | Perrigo Company PLC / 2280 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-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-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-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-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 Package NDCs: 59779-425-53; 59779-425-62 | 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-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 Package NDCs: 11822-0571-1; 11822-0571-2; 11822-0571-3; 11822-0571-4; 11822-0571-5 | 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
| 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-0665-2021 | 07-07-2021 | Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA, 19087, NDC 46122-649-71 | Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet' | LNK International, Inc. / 8,472 bottles | Class III | Terminated |
| D-0719-2021 | 07-07-2021 | Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520, Made in India, NDC 65862-420-05 Package NDCs: 65862-419-20; 65862-419-01; 65862-419-05; 65862-419-99; 65862-420-20; 65862-420-01; 65862-420-05; 65862-420-99 | Presence of Foreign Substance- Potential of metal contamination. | Aurobindo Pharma USA Inc. / 3800 bottles | Class II | Terminated |
| D-0652-2021 | 07-02-2021 | NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 50 count unit dose carton, NDC 0904-7080-06: Distributed by: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA Package NDCs: 0904-7080-06; 0904-7080-61; 0904-7081-06; 0904-7081-61; 0904-7082-04; 0904-7082-06 | Failed Dissolution Specification: Out of specification for dissolution during routine stability testing. | The Harvard Drug Group / 504 Cartons of 50 count each; 372 Cartons of 100 count each | Class II | Terminated |
| D-0772-2021 | 07-02-2021 | Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-223-21. Package NDCs: 10702-223-21 | Temperature abuse: the firm received customer complaints of unusual grittiness in the product. | KVK-Tech, Inc. / 1,692 bottles | Class I | Terminated |
| D-0803-2021 | 06-30-2021 | MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx only, Promise Pharmacy 31818 US Hwy 19N Palm Harbor FL 34684 1-888-3PROMIS | Lack of processing controls | Promise Pharmacy, LLC / 57 vials | Class II | Terminated |
| D-0697-2021 | 06-30-2021 | Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 4 fl. oz./119 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-01 | CGMP Deviations: Does not meet monograph for denaturant. | Cascade Kelly Holdings LLC / | Class II | Terminated |
| D-0698-2021 | 06-30-2021 | Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 8 fl. oz./236 mL, Alcohol 80% v/v, Manufactured by: Cascade Kelly Holdings LLC, NDC 80253-001-02 | CGMP Deviations: Does not meet monograph for denaturant. | Cascade Kelly Holdings LLC / | Class II | Terminated |
| D-0720-2021 | 06-29-2021 | Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, NDC# 0002-7597-01 Package NDCs: 0002-4112-30; 0002-4115-30; 0002-4116-30; 0002-4117-30; 0002-4415-30; 0002-4420-30; 0002-4453-01; 0002-4453-85; 0002-4454-01; 0002-4454-85; 0002-4455-01; 0002-4455-85; 0002-4456-01; 0002-4456-85; 0002-7597-01 | cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product. | Eli Lilly & Company / 36,540 vials | Class II | Terminated |
| D-0651-2021 | 06-25-2021 | Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. Vial NDC 63323-487-07, Tray NDC 63323-487-37 Package NDCs: 63323-492-04; 63323-492-27; 63323-492-09; 63323-492-57; 63323-492-07; 63323-492-37; 63323-492-03; 63323-492-31; 63323-491-01; 63323-491-57; 63323-495-09; 63323-495-27; 63323-495-04; 63323-495-07; 63323-485-01; 63323-485-27; 63323-485-03; 63323-485-57; 63323-486-01; 63323-486-17; 63323-486-02; 63323-486-27; 63323-486-05; 63323-486-57; 63323-484-57; 63323-489-02; 63323-489-27; 63323-489-03; 63323-489-21; 63323-489-01; 63323-489-17; 63323-488-07; 63323-488-37; 63323-488-03; 63323-488-31; 63323-488-01; 63323-488-17; 63323-481-01; 63323-481-57; 63323-483-03; 63323-483-27; 63323-483-01; 63323-483-57; 63323-482-01; 63323-482-17; 63323-482-03; 63323-482-27; 63323-482-05; 63323-482-57; 63323-487-01; 63323-487-17; 63323-487-07; 63323-487-37; 63323-487-03; 63323-487-31 | Low out of specification results for epinephrine assay. | Fresenius Kabi USA LLC / 234,800 vials | Class II | Terminated |
| D-0655-2021 | 06-23-2021 | LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vials) per box, Rx only, Mfd by Partner Therapeutics, Inc. Lexington, MA 02421, NDC 71837-5843-5 Package NDCs: 71837-5843-1; 71837-5843-5 | FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint. | Partner Therapeutics Inc / 32,260 vials | Class III | Terminated |
| D-0690-2021 | 06-22-2021 | Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC 52565-033-60) Rx Only, Manufactured by: Teligent Pharma, Inc. , Buena, NJ 08310, | Failed Impurities/Degradation Specifications | Teligent Pharma, Inc. / 22,824 tubes | Class III | Terminated |
| D-0689-2021 | 06-22-2021 | Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59 | Failed Impurities/Degradation Specifications | Teligent Pharma, Inc. / 7872 tubes | Class III | Terminated |
| D-0643-2021 | 06-22-2021 | 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 HoYu (US) Logistics Inc UPC 6 926645 716288 | Subpotent | HOYU(US) LOGISTICS INC / 30,880 bottles | Class II | Ongoing |
| D-0691-2021 | 06-22-2021 | Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured in Dominican Republic: by Ardil Comercial S.R.L., Santo Domingo, Dominican Republic UPC 7 487040 301587 | Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles. | Ardil Comercial S.R.L. / 1,260 bottles | Class I | Ongoing |
| D-0694-2021 | 06-21-2021 | Prairie Wolf Distillery Alcohol Antiseptic 80%, Topical Solution Hand Sanitizer, packaged in a) (16.9oz) 500 mL (UPC 8 60003 31899 7, NDC: 73891-100-14); and b) (20oz) 591 mL (UPC 8 60003 65984 7 NDC: 73891-100-15) bottles, Prairie Wolf Distillery, Guthrie, Oklahoma | Hand sanitizer packaged in bottles that resemble beverage containers. | Prairie Wolf Spirits / Unknown | Class I | Terminated |
| D-0661-2021 | 06-18-2021 | Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton NDC# 0703-4714-01, Vial NDC# 0703-4714-71 | Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber. | Teva Pharmaceuticals USA / 10,425 vials | Class I | Terminated |
| D-0653-2021 | 06-18-2021 | B-Force, Homeopathic, 1 Fl Oz (30 mL) bottle, Distributed by: BioActive Nutritional, Inc., Melbourne, FL 32935, NDC 43857-0576-1 Package NDCs: 43857-0576-1 | Superpotent | Grato Holdings, Inc. / 1480 bottles | Class III | Terminated |
| D-0729-2021 | 06-16-2021 | Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottle, Distributed by: Walmart Inc., Bentoville, AR 72716, NDC 79903-052-10 | cGMP deviations: Discolored acetaminophen | Spirit Pharmaceuticals / N/A | Class II | Terminated |
| D-0660-2021 | 06-10-2021 | Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna, Goa, India Manufactured for Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL, 33323, NDC 69097-261-02. Package NDCs: 69097-259-02; 69097-259-05; 69097-259-15; 69097-261-02; 69097-261-05; 69097-261-15 | CGMP Deviations | CIPLA / 7228 bottles | Class II | Terminated |
| D-0632-2021 | 06-09-2021 | QiYu Hand Sanitizer Gel, ethanol, 500 mL bottles (pump), Manufacturer Guangzhou Minghui Cosmetics Co., Ltd., Baiyun District, Guanzhou | Subpotent | World Source Llc / 6,300 bottles | Class II | Terminated |
| D-0631-2021 | 06-09-2021 | Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13 | Failed Impurities Specification: Out of specification when measuring the impurity degradant D level. | AVKARE Inc. / 10 cartons | Class III | Terminated |
| D-0701-2021 | 06-09-2021 | Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0469-56 Package NDCs: 0069-0468-56; 0069-0469-56; 0069-0469-03; 0069-0471-03 | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit | Pfizer Inc. / 69,6396 bottles | Class II | Ongoing |
| D-0699-2021 | 06-09-2021 | Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc., NY, NY 10017, Made in Ireland. NDC 0069-0468-56 Package NDCs: 0069-0468-56; 0069-0469-56; 0069-0469-03; 0069-0471-03 | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit | Pfizer Inc. / 59,232 bottles | Class II | Ongoing |
| D-0650-2021 | 06-09-2021 | Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For Subcutaneous Use. Single-Dose Prefilled Syringe. Product of France, Manufactured by: Genentech, Inc. A Member of the Roche Group, South San Francisco, CA 9480-4990. NDC: 50242-215-01 Package NDCs: 50242-040-62; 50242-040-86; 50242-214-01; 50242-214-86; 50242-214-03; 50242-214-55; 50242-214-99; 50242-214-83; 50242-215-86; 50242-215-01; 50242-215-03; 50242-215-55; 50242-215-99; 50242-215-83; 50242-227-01; 50242-227-55; 50242-227-99; 50242-227-86 | Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point. | Genentech Inc / 88,620 prefilled syringes | Class II | Terminated |
| D-0700-2021 | 06-09-2021 | Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets), 3 Continuing Weeks (1 mg x 42 tablets), Rx Only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, Made in Ireland, NDC 0069-0471-03. Package NDCs: 0069-0468-56; 0069-0469-56; 0069-0469-03; 0069-0471-03 | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit | Pfizer Inc. / 350,985 cartons | Class II | Ongoing |
| D-0639-2021 | 06-08-2021 | Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA, NDC 68682-170-30 | Failed Impurities/Degradation Specifications | Bausch Health Companies, Inc. / 37,797 bottles | Class III | Terminated |
| D-0638-2021 | 06-08-2021 | Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, 08807, USA, NDC 0187-1704-05. | Failed Impurities/Degradation Specifications | Bausch Health Companies, Inc. / 2,691 bottles | Class III | Terminated |
