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-0571-2021 | 03-15-2021 | Colcrys (colchicine, USP) tablets 0.6 mg 30 tablets Rx only Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015,NDC 64764-119-07 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 160 bottles | Class II | Terminated |
| D-0451-2021 | 03-15-2021 | NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAPID DISSOLUTION (NOT SUBLINGUAL) Package NDCs: 72618-3000-2; 72618-3001-1; 72618-3001-2; 72618-3001-4 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1240 CARTON | Class II | Terminated |
| D-0500-2021 | 03-15-2021 | Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured under license from: Kowa Company, Limited Tokyo 103-8433 Japan Tablets Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd Nagoya 462-0024 Japan Package NDCs: 66869-104-90; 66869-204-90; 66869-204-07; 66869-404-90; 66869-404-07 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 453 bottles | Class II | Terminated |
| D-0512-2021 | 03-15-2021 | Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60 Distributed by: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 USA Package NDCs: 0904-5306-60; 0904-5306-80; 0904-5306-61; 0904-5306-24; 0904-2056-61; 0904-2035-24 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 88 bottles | Class II | Terminated |
| D-0592-2021 | 03-15-2021 | Amantadine Hydrochloride Tablets 100 mg 100-count bottle, Rx Only Manufactured by Upsher-Smith Laboratories, Inc. Maple Grove, MN 55369, NDC 0832-0111-00 Package NDCs: 0832-0111-00; 0832-0111-50; 0832-0111-89; 0832-0111-03 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 271 bottles | Class II | Terminated |
| D-0564-2021 | 03-15-2021 | Cefazolin for Injection, USP 1 gram per vial Rx Only Single-use Vial Sterile Manufactured in Austria by Sandoz GmbH for Sandoz, Inc., Princeton, NJ 08540, NDC 0781-3451-70 Package NDCs: 0781-3450-70; 0781-3450-95; 0781-3451-70; 0781-3451-96; 0781-3451-95 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 8 vials | Class II | Terminated |
| D-0486-2021 | 03-15-2021 | Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets 30 Tablets Rx Only NDC 49702-231-13 Manufactured for: Viiv Healthcare Research Triangle Park, NC 27709 by GlaxoSmithKline Research Triangle Park, NC 27709 Package NDCs: 49702-231-13; 49702-258-37; 49702-272-59 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 2264 bottles | Class II | Terminated |
| D-0568-2021 | 03-15-2021 | CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP,150MG 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-692-01 Package NDCs: 63304-692-01; 63304-692-05; 63304-692-77; 63304-692-03; 63304-693-16; 63304-693-01; 63304-693-03; 63304-693-05; 63304-693-77; 63304-693-11; 63304-693-62 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 223 bottles | Class II | Terminated |
| D-0499-2021 | 03-15-2021 | Auryxia (ferric citrate) tablets 210 mg* 200 Tablets Rx Only NDC 59922-631-01 Manufactured for and distributed by: Keryx Biopharmaceuticals, Inc. 750 Lexington Avenue, 20th Floor New York, NY 10022 USA Package NDCs: 59922-631-01 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 136 bottles | Class II | Terminated |
| D-0593-2021 | 03-15-2021 | HALOPERIDOL TABLETS 20mg, USP, 100-count bottle, Rx Only Distributed by: Usher-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC: 0832-1560-11 Package NDCs: 0832-1510-11; 0832-1520-11; 0832-1520-89; 0832-1520-01; 0832-1530-11; 0832-1540-11; 0832-1540-89; 0832-1540-01; 0832-1550-11; 0832-1550-89; 0832-1550-01; 0832-1560-11 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 35 BOTTLE | Class II | Terminated |
| D-0485-2021 | 03-15-2021 | Theophylline (Anhydrous) Extended-Release Tablets 400 mg 100 Tablets Rx Only NDC 68462-380-01 Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Package NDCs: 68462-380-01; 68462-380-05; 68462-356-01; 68462-356-05 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 141 bottles | Class II | Terminated |
| D-0584-2021 | 03-15-2021 | Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured by: Torrent Pharmaceuticals, LTD Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-203-30 Package NDCs: 13668-202-30; 13668-202-90; 13668-202-05; 13668-203-30; 13668-203-05; 13668-203-90 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 37 bottles | Class II | Terminated |
| D-0583-2021 | 03-15-2021 | Darifenacin Extended-release Tablets 7.5 mg 30 Tablets Rx only Manufactured by: Torrent Pharmaceuticals LTD. Indrad-382 721, India Manufactured for: Torrent Pharma Inc. Basking Ridge, NJ 07920, NDC 13668-202-30 Package NDCs: 13668-202-30; 13668-202-90; 13668-202-05; 13668-203-30; 13668-203-05; 13668-203-90 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 52 bottles | Class II | Terminated |
| D-0590-2021 | 03-15-2021 | VIMPAT (lacosamide) Tablets, 200mg, 60-count bottle, Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080, NDC 0131-2480-35 Package NDCs: 0131-2477-35; 0131-2477-60; 0131-2477-99; 0131-2478-35; 0131-2478-60; 0131-2478-99; 0131-2479-35; 0131-2479-60; 0131-2479-99; 0131-2480-35; 0131-2480-60; 0131-2480-99; 0131-1810-67; 0131-5410-70; 0131-5410-71; 0131-5410-72 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 882 bottles | Class II | Terminated |
| D-0404-2021 | 03-15-2021 | Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC 0074-3333-30 Abbott Laboratories North Chicago, IL 60064, U.S.A. Package NDCs: 0074-3333-30; 0074-1940-63; 0074-3399-30; 0074-2340-30 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 362 bottles | Class II | Terminated |
| D-0476-2021 | 03-15-2021 | cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech Package NDCs: 50242-041-64; 50242-041-10 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1473 vials | Class II | Terminated |
| D-0434-2021 | 03-15-2021 | Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 9 mcg/4.8 mcg per inhalation For Oral Inhalation only 120 inhalations Rx Only NDC 0310-4600-12 Mfd for: AstraZeneca Pharmaceuticals, LP, Wilmington, DE 19850 Package NDCs: 0310-4600-12; 0310-4600-28; 0310-4600-39 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 355 inhalers | Class II | Terminated |
| D-0496-2021 | 03-15-2021 | Enbrace HR 30 ct. Softgels Enhanced Prenatal Vitamin Supplement Rx NDC 64661-650-30 Manufactured for: JAYMAC Pharmaceuticals, LLC, Sunset, LA 70584 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 11 bottles | Class II | Terminated |
| D-0481-2021 | 03-15-2021 | TRELEGY ELLIPTA (FLUTICASONE FUROATE, UMEDIDINIUM AND VILANTEROL INHALATION POWDER) 100-62.5-25MCG 60; NDC/UPC 0173-0893-10; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL Package NDCs: 0173-0887-10; 0173-0887-14; 0173-0887-61; 0173-0893-10; 0173-0893-14; 0173-0893-61 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 4065 CARTON | Class II | Terminated |
| D-0412-2021 | 03-15-2021 | Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tablets Rx only NDC 62332-115-31 Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA Package NDCs: 62332-115-30; 62332-115-31; 62332-115-91; 62332-116-30; 62332-116-31; 62332-116-71; 62332-117-30; 62332-117-31; 62332-117-71; 2005005745 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 71 bottles | Class II | Terminated |
| D-0425-2021 | 03-15-2021 | TRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML ; NDC/UPC 60505-0593-4; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 325 CARTONS | Class II | Terminated |
| D-0484-2021 | 03-15-2021 | EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS Package NDCs: 68462-321-90; 68462-321-10; 68462-321-30; 68462-322-30; 68462-322-90; 68462-322-10; 68462-323-30; 68462-323-90; 68462-323-05; 68462-324-30; 68462-324-90; 68462-324-05 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 7 CARTON | Class II | Terminated |
| D-0457-2021 | 03-15-2021 | Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets 5 mg/1000 mg 30 tablets Rx only NDC 0597-0275-33 Dist. by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA Package NDCs: 0597-0270-12; 0597-0270-73; 0597-0270-94; 0597-0275-33; 0597-0275-81; 0597-0275-88 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 52 bottles | Class II | Terminated |
| D-0518-2021 | 03-15-2021 | BENZOYL PEROXIDE WASH 5% 148ML; NDC/UPC 0536-1259-63; OTC; LIQUID | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 37 BOTTLE | Class II | Terminated |
| D-0459-2021 | 03-15-2021 | Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0300-45 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA Package NDCs: 0597-0280-36; 0597-0280-73; 0597-0280-90; 0597-0290-20; 0597-0290-59; 0597-0290-74; 0597-0295-61; 0597-0295-78; 0597-0295-88; 0597-0300-20; 0597-0300-45; 0597-0300-93 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 751 bottles | Class II | Terminated |
| D-0591-2021 | 03-15-2021 | Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-570-66 Package NDCs: 50474-370-66; 50474-470-66; 50474-470-09; 50474-470-14; 50474-570-66; 50474-570-09; 50474-570-14; 50474-670-66; 50474-770-66; 50474-770-09; 50474-770-14; 50474-870-15; 50474-970-63; 50474-970-75 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 101 bottles | Class II | Terminated |
| D-0509-2021 | 03-15-2021 | Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg 30 Tablets Rx Only NDC 33342-192-07 Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India Package NDCs: 33342-190-07; 33342-190-10; 33342-190-12; 33342-190-44; 33342-191-07; 33342-191-10; 33342-191-12; 33342-191-44; 33342-192-07; 33342-192-10; 33342-192-12; 33342-192-44; 33342-193-07; 33342-193-10; 33342-193-12; 33342-193-44 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 33 bottles | Class II | Terminated |
| D-0561-2021 | 03-15-2021 | Budesonide and Formoterol Fumarate Dihydrate Inhalation Aerosol 80/4.5 budesonide 80 mcg/formoterol fumarate dihydrate 4.5 mcg Inhalation Aerosol 120 inhalations Rx only Manufactured for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850, NDC 0310-7372-20 Package NDCs: 0310-7370-20; 0310-7372-20 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 905 inhalers | Class II | Terminated |
| D-0435-2021 | 03-15-2021 | xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Manufactured by: Bristol-Myers Squibb Manufacturing Company Humacao, Puerto Rico 00791 Package NDCs: 0310-6270-30; 0310-6270-95; 0310-6280-30; 0310-6280-95; 0310-6250-30; 0310-6250-95; 0310-6260-30; 0310-6260-60; 0310-6260-94; 0310-6260-95; 0310-6225-60; 0310-6225-94 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 664 bottles | Class II | Terminated |
| D-0538-2021 | 03-15-2021 | Lamotrigine Extended-Release Tablets 250 mg 30 Tablets Rx Only NDC 49884-604-11 Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Zhejiang 317024 China For Par Pharmaceutical Companes, Inc. Spring Valley, NY 10977 U.S.A. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 131 bottles | Class II | Terminated |
| D-0464-2021 | 03-15-2021 | Nadolol Tablets, USP 40 mg 100 Tablets Rx Only NDC 69097-868-07 Manufactured for: Cipla USA Inc. 9100 S. Dadeland Blvd., Suite 1599 Miami, FL 33156 Package NDCs: 69097-867-07; 69097-867-15; 69097-867-02; 69097-868-02; 69097-868-07; 69097-868-15; 69097-869-02; 69097-869-07; 69097-869-15 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 40 bottles | Class II | Terminated |
| D-0544-2021 | 03-15-2021 | Polyethylene Glycol 3350 Powder for Solution, Laxative Net Wt 4.1 oz (119 g) 7 Once-Daily Doses NDC 45802-868-01 Distributed by Perrigo Allegan, MI 49010 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 163 bottles | Class II | Terminated |
| D-0545-2021 | 03-15-2021 | POLYETHYLENE GLYCOL 3350 Powder for Solution Osmotic Laxative 14 once-daily doses 14 Packet- Newt Wt. 0.5 oz (17g) each NDC 45802-868-66 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 934 boxes | Class II | Terminated |
| D-0433-2021 | 03-15-2021 | Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd. for: AstraZeneca LP, Wilmington, DE 19850 Package NDCs: 0186-0777-08; 0186-0777-60; 0186-0777-18; 0186-0777-39; 0186-0777-28; 0186-0776-60; 0186-0776-94 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1278 bottles | Class II | Terminated |
| D-0461-2021 | 03-15-2021 | Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactured by: Jubilant Generics Ltd. Roorkee-247661, India Package NDCs: 59746-360-30; 59746-360-90; 59746-360-05; 59746-360-03; 59746-361-30; 59746-361-90; 59746-361-05; 59746-361-03; 59746-362-30; 59746-362-90; 59746-362-05; 59746-362-03; 59746-393-30; 59746-393-90; 59746-393-67; 59746-393-32 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 20 bottles | Class II | Terminated |
| D-0482-2021 | 03-15-2021 | Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) 100 mcg/62.5 mcg/25 mcg; 1 ELLIPTA Inhaler containing 30 doses (60 blisters total) Rx Only NDC 0173-0887-10 GlaxoSmithKline Research Triangle Park, NC 27709 Package NDCs: 0173-0887-10; 0173-0887-14; 0173-0887-61; 0173-0893-10; 0173-0893-14; 0173-0893-61 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 903 inhalers | Class II | Terminated |
| D-0402-2021 | 03-15-2021 | Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Units Rx only NDC 0032-3016-13 100 Capsules Marketed by: AbbVie Inc. North Chicago, IL 60064, U.S.A. Package NDCs: 0032-1203-70; 0032-1203-64; 0032-1206-07; 0032-1206-01; 0032-1206-56; 0032-1212-07; 0032-1212-01; 0032-1212-46; 0032-1212-13; 0032-1224-07; 0032-1224-01; 0032-1224-46; 0032-3016-28; 0032-3016-13; 0032-3016-50; 0032-3016-12; 0032-0045-70; 0032-0045-30; 0032-0046-30; 0032-0046-70; 0032-0047-30; 0032-0047-70; 0032-2636-70; 0032-2636-01; 0032-2636-30; 0032-2637-70; 0032-2637-01; 0032-2637-30 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1669 bottles | Class II | Terminated |
| D-0570-2021 | 03-15-2021 | Trokendi XR (topiramate) extended-release capsules 100 mg 30 Capsules Rx only, Manufactured by: Catalent Pharma Solutions Winchester, KY 40391 USA Manufactured for: Supernus Pharmaceuticals, Inc. Rockville, MD 20850 USA, NDC 17772-103-30 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 490 bottles | Class II | Terminated |
| D-0507-2021 | 03-15-2021 | NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz. (473 mL) NDC 68047-186-16 Distributed by: Larken Laboratories, Inc. Canton, MS 39046 Package NDCs: 68047-186-16 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 24 bottles | Class II | Terminated |
| D-0581-2021 | 03-15-2021 | Desvenlafaxine Extended-Release Tablets 25 mg 30 Tablets Rx Only NDC 0591-4060-30 Manufactured by: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Package NDCs: 0591-4060-30; 0591-3659-30; 0591-3660-30 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 57 bottles | Class II | Terminated |
| D-0572-2021 | 03-15-2021 | Children's Loratadine Oral Solution USP, 5 mg/5 mL (Antihistamine) Allergy Grape Flavor 4 FL OZ (120 mL) NDC 51672-2131-8 Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 Package NDCs: 51672-2131-4; 51672-2131-8; 51672-2131-1 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 2907 bottles | Class II | Terminated |
| D-0576-2021 | 03-15-2021 | PENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4125-73 Package NDCs: 0093-1172-01; 0093-1172-10; 0093-1174-01; 0093-1174-10; 0093-4125-73; 0093-4125-74; 0093-4127-73; 0093-4127-74 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 91 bottles | Class II | Terminated |
| D-0520-2021 | 03-15-2021 | CARBIDOPA AND LEVORDOPA TABLETS, USP 25MG/100MG 100 TABLETS; NDC/UPC 51862-856-01; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 407 BOXES | Class II | Terminated |
| D-0407-2021 | 03-15-2021 | FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES Package NDCs: 27241-118-04; 27241-118-05; 27241-119-04; 27241-119-05; 27241-120-04; 27241-120-05 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 106 BOXES | Class II | Terminated |
| D-0470-2021 | 03-15-2021 | Phenobarbital Tablets, USP 32.4 mg 100 tablets Rx only NdC 13517-111-01 Manufactured for: e5 Pharma, LLC., Boca Raton, FL 33432 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1 bottle | Class II | Terminated |
| D-0551-2021 | 03-15-2021 | Triamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: Perrigo, Allegan, MI 49010,NDC 45802-054-36 Package NDCs: 45802-054-35; 45802-054-05; 45802-054-36; 45802-055-35; 45802-055-36; 45802-055-05; 45802-049-35 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 178 tubes | Class II | Terminated |
| D-0508-2021 | 03-15-2021 | TRI-LO-MARZIA 0.180MG/0.025MG; 0.215 MG/0.025MG AND 0.250MG/0.025MG 3X28 BPK; NDC/UPC 68180-837-73; RX; TABLETS Package NDCs: 68180-837-73 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 60 CARTON | Class II | Terminated |
| D-0473-2021 | 03-15-2021 | Narcan (naloxone HCl) Nasal Spray 4 mg Two Pack This box contains two (2) 4-mg doses of naloxone HCl in 0.1 mL of nasal spray. 0.1 mL intranasal spray per unit For use in the nose only Rx only NDC 69547-353-02 Distributed by Adapt Pharma, Inc. Radnor, PA 19087 USA Package NDCs: 69547-353-02 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 11189 plungers | Class II | Terminated |
| D-0554-2021 | 03-15-2021 | Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only NDC 0069-0469-03 Distributed by Pfizer Labs Division of Pfizer Inc., NY, NY 10017 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 940 cartons | Class II | Terminated |
| D-0483-2021 | 03-15-2021 | Verapamil Hydrochloride Extended-Release Tablets USP 120 mg Rx Only NDC 68462-292-01 Manufactured by: Glenmark Generics Ltd Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Generics Inc., USA Mahwah, NJ 07430 Package NDCs: 68462-292-90; 68462-292-01; 68462-292-05; 68462-293-90; 68462-293-01; 68462-293-05; 68462-260-30; 68462-260-90; 68462-260-01; 68462-260-05; 68462-260-10 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 513 bottles | Class II | Terminated |
| D-0424-2021 | 03-15-2021 | ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 135 CARTON | Class II | Terminated |
| D-0442-2021 | 03-15-2021 | Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 capsules Rx only NDC 64597-301-60 Manufactured by Patheon, Inc. Whitby, ON L1N 5Z5, Canada Package NDCs: 64597-301-13; 64597-301-60 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 255 bottles | Class II | Terminated |
| D-0463-2021 | 03-15-2021 | Meloxicam Tablets, USP 7.5 mg 100 Tablets Rx Only NDC 69097-158-07 Manufactured for: Cipla USA, Inc. 9100 S. Dadeland Blvd., Suite 1500 Miami, FL 33156 Package NDCs: 69097-158-15; 69097-158-07; 69097-158-12; 69097-159-12; 69097-159-07; 69097-159-15 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 576 bottles | Class II | Terminated |
| D-0550-2021 | 03-15-2021 | HYDROCORTISONE ACET 30MG 12; RX; SUPPOSITORY,Rx Only, Distributed by: Perrigo, Allegan, MI 49010, NDC: 0574-7093-12 Package NDCs: 0574-7090-12; 0574-7093-12 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 95 suppositories | Class II | Terminated |
| D-0535-2021 | 03-15-2021 | CIPRODEX (CIPROFLOXACIN 0.3 AND DEXAMETHASONE 0.1%) 7.5ML; NDC/UPC 0078-0799-75; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 341 CARTON | Class II | Terminated |
| D-0495-2021 | 03-15-2021 | TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules; NDC/UPC 71858-0055-4; RX; CAPSULES Package NDCs: 71858-0013-4; 71858-0013-1; 71858-0013-2; 71858-0012-4; 71858-0012-1; 71858-0012-2; 71858-0005-4; 71858-0005-1; 71858-0005-2; 71858-0010-4; 71858-0010-1; 71858-0010-2; 71858-0015-4; 71858-0015-1; 71858-0015-2; 71858-0020-4; 71858-0020-1; 71858-0020-2; 71858-0025-4; 71858-0025-1; 71858-0025-2; 71858-0030-4; 71858-0030-1; 71858-0030-2; 71858-0035-4; 71858-0035-1; 71858-0035-2; 71858-0040-4; 71858-0040-1; 71858-0040-2; 71858-0045-4; 71858-0045-1; 71858-0045-2; 71858-0050-4; 71858-0050-1; 71858-0050-2; 71858-0055-4; 71858-0055-1; 71858-0055-2; 71858-0060-4; 71858-0060-1; 71858-0060-2; 71858-0017-4; 71858-0017-1; 71858-0017-2 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 25 boxes | Class II | Terminated |
| D-0489-2021 | 03-15-2021 | bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 Package NDCs: 23155-191-10; 23155-191-01; 23155-192-10; 23155-192-01 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 32 bottles | Class II | Terminated |
| D-0556-2021 | 03-15-2021 | Chantix (varenicline) Tablets Starting Pack Contains: 1 Starting Week (0.5 mgx11 tablets) 3 Continuing Weeks (1 mgx42 tablets) Rx only NDC 0069-0471-03 Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY 10017 Package NDCs: 0069-0468-56; 0069-0469-56; 0069-0469-28; 0069-0471-03; 0069-0471-28 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 1040 cartons | Class II | Terminated |
| D-0453-2021 | 03-15-2021 | Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule Rx only NDC 0597-0075-41 Manufactured by: Boehringer Ingelheim (BI) Pharma GmbH & Co. KG Ingelheim, Germany Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Pfizer, Inc. New York, NY 10017 USA Package NDCs: 0597-0075-41; 0597-0075-75; 0597-0075-47 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 2611 inhalers | Class II | Terminated |
| D-0513-2021 | 03-15-2021 | Acne Medication Benzoyl Peroxide Gel USP, 5% Net Wt 1.5 oz (42.5 g) NDC 0536-1055-56 Distributed by: Rugby Laboratories 31778 Enterprise Drive, Livonia, MI 48150 Package NDCs: 0536-1055-56; 0536-1055-25; 0536-1055-57 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 189 tubes | Class II | Terminated |
| D-0449-2021 | 03-15-2021 | Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-025-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612 USA Package NDCs: 59385-021-01; 59385-021-60; 59385-022-01; 59385-022-60; 59385-023-01; 59385-023-60; 59385-024-01; 59385-024-60; 59385-025-01; 59385-025-60; 59385-026-01; 59385-026-60; 59385-027-01; 59385-027-60 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 47 cartons | Class II | Terminated |
| D-0527-2021 | 03-15-2021 | Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/day Rx only NDC 0378-4623-26 Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-4619-16; 0378-4619-26; 0378-4620-16; 0378-4620-26; 0378-4621-16; 0378-4621-26; 0378-4622-16; 0378-4622-26; 0378-4623-16; 0378-4623-26 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 72 cartons | Class II | Terminated |
| D-0428-2021 | 03-15-2021 | Timolol Maleate Ophthalmic Solution, USP 0.5% 2.5 mL Sterile For Topical Application In The Eye Rx Only NDC 60505-1005-4 Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 31 droptainers | Class II | Terminated |
| D-0528-2021 | 03-15-2021 | Epinephrine Injection, USP Auto-Injectors in all strengths, packs and styles Manufactured for Mylan Specialty L.P., Morgantown, WV , NDC: 9502-500-01, 49502-500-02, 49502-500-92, 49502-501-01 Package NDCs: 49502-500-01; 49502-500-02; 49502-500-92; 49502-501-01; 49502-501-02; 49502-501-92 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 620 injector | Class II | Terminated |
| D-0510-2021 | 03-15-2021 | TRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET 10X10UD; NDC/UPC 0904-6868-61; RX; TABLETS Package NDCs: 0904-6868-61; 0904-6869-61; 0904-7212-61 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 91 CARTON | Class II | Terminated |
| D-0423-2021 | 03-15-2021 | Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg oseltamivir base after constitution. 60 mL (usable volume after constitution) Rx Only NDC 47781-384-26 Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA Package NDCs: 47781-384-26 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 15885 bottles | Class II | Terminated |
| D-0579-2021 | 03-15-2021 | Balziva 28 Day (norethindrone and ethinyl estradiol tablets USP) 6 Blister Card Dispensers, 28 tablets each, Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-9034-58 Package NDCs: 0555-9034-79; 0555-9034-58 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 23 bottles | Class II | Terminated |
| D-0553-2021 | 03-15-2021 | Methotrexate Injection, USP 50 mg/2mL (25 mg/mL) 5 x 2mL Single-Dose Vials, Sterile, Rx Only, Distributed by Hospira, Inc. Lake Forest, IL 60045. NDC 61703-350-38. Package NDCs: 61703-350-37; 61703-350-38; 61703-408-41 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 341 vials | Class II | Terminated |
| D-0450-2021 | 03-15-2021 | SYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS; NDC 59385-041-30; RX; TABLETS Package NDCs: 59385-041-30; 59385-041-07 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 67 BOXES | Class II | Terminated |
| D-0523-2021 | 03-15-2021 | Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets. Rx only NDC 0006-0335-30 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08880, USA Package NDCs: 0006-0005-10; 0006-0005-30; 0006-0005-13; 0006-0033-10; 0006-0033-30; 0006-0033-13; 0006-0325-10; 0006-0325-30; 0006-0325-13; 0006-0335-10; 0006-0335-30; 0006-0335-13 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 299 cartons | Class II | Terminated |
| D-0431-2021 | 03-15-2021 | edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/25 mg *Each tablet contains: 42.68 mg azilsartan kamedoxomil (equivalent to 40 mg azilsartan medoxomil) and 25 mg chlorthalidone. 30 Tablets Rx Only NDC 60631-425-30 Manufactured for Arbor Pharmaceuticals Atlanta, GA 30328 Package NDCs: 60631-412-30; 60631-425-30 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 273 bottles | Class II | Terminated |
| D-0429-2021 | 03-15-2021 | Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328 Package NDCs: 60631-040-07; 60631-040-30; 60631-040-77; 60631-080-07; 60631-080-30; 60631-080-77 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 328 bottles | Class II | Terminated |
| D-0526-2021 | 03-15-2021 | Levothyroxine Sodium Tablets, USP 125 mcg (0.125 mg) 90 Tablets Rx only NDC 0378-1813-77 Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Package NDCs: 0378-1800-77; 0378-1800-10; 0378-1803-77; 0378-1803-10; 0378-1805-77; 0378-1805-10; 0378-1807-77; 0378-1807-10; 0378-1809-77; 0378-1809-10; 0378-1811-77; 0378-1811-10; 0378-1813-77; 0378-1813-10; 0378-1823-77; 0378-1823-10; 0378-1815-77; 0378-1815-10; 0378-1817-77; 0378-1817-10; 0378-1819-77; 0378-1819-10; 0378-1821-77 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 112 bottles | Class II | Terminated |
| D-0542-2021 | 03-15-2021 | Benzoyl Peroxide 2.5% Aqueous Base, Acne Treatment Gel Net Wt. 2.1 oz (60 g) NDC 45802-101-96 Distributed By Perrigo Allegan, MI 49010 Package NDCs: 45802-101-96 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 5 tubes | Class II | Terminated |
| D-0426-2021 | 03-15-2021 | ENOXAPARIN DOFIUM INJRVYION, UPD 150MG/1ML 10X1ML SINGLE DOSE SYRINGES; NDC/UPC 60505-0798-4; RX; SYRINGES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 64 BOXES | Class II | Terminated |
| D-0562-2021 | 03-15-2021 | Medroxyprogesterone acetate injectable suspension, USP 150 mg per mL 1 mL Prefilled Syringe Rx only NDC 59762-4538-2 Distributed by: Greenstone, LLC. Peapack, NJ 07977 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 286 syringes | Class II | Terminated |
| D-0497-2021 | 03-15-2021 | Tylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever Reducer 20 Liquid Gels 325 mg each NDC 50580-487-20 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 37 bottles | Class II | Terminated |
| D-0517-2021 | 03-15-2021 | DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL OINTMENT 28GM ; NDC/UPC 0536-1211-95; OTC; OINTMENT Package NDCs: 0536-1211-95 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 701 CARTON | Class II | Terminated |
| D-0413-2021 | 03-15-2021 | BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS Package NDCs: 62332-508-17 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 152 CARTON | Class II | Terminated |
| D-0582-2021 | 03-15-2021 | Sulindac Tablets, USP, 200mg 100-count bottles, Rx Only, Manufactured by: Epic Pharma, LLC, Laurelton, NY 11413, NDC 42806-011-01 Package NDCs: 42806-018-01; 42806-018-05; 42806-018-10; 42806-011-01; 42806-011-05; 42806-011-10 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 92 bottles | Class II | Terminated |
| D-0491-2021 | 03-15-2021 | Calcium Acetate Capsules 667 mg 200 Capsules Rx only NDC 23155-531-02 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 Package NDCs: 23155-531-02; 23155-531-10; 23155-531-18 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 35 bottles | Class II | Terminated |
| D-0430-2021 | 03-15-2021 | edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/12.5 mg 30 Tablets Rx Only NDC 60631-412-30 Manufactured for: arbor Pharmaceuticals, LLC. Atlanta, GA 30328 Package NDCs: 60631-412-30; 60631-425-30 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 244 bottles | Class II | Terminated |
| D-0472-2021 | 03-15-2021 | Banzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by Eisai Co., Ltd. Marketed by Eisai Inc. Woodcliff Lake, NJ 07677 Package NDCs: 62856-582-52; 62856-582-04; 62856-583-14; 62856-583-52; 62856-584-46 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 30 bottles | Class II | Terminated |
| D-0320-2021 | 03-15-2021 | Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx only, Distributor: Ferring Pharmaceuticals, Inc., Parsippany, NJ 07054 USA, Manufactured by: Sun Pharmaceutical Industries Ltd, Halol, Gujarat, India Made in India, NDC 55566-1000-1. | Failed Impurities/Degradation Specifications | SUN PHARMACEUTICAL INDUSTRIES INC / 91,211 syringes | Class II | Terminated |
| D-0408-2021 | 03-15-2021 | OFLOXACIN 0.3% 5ML OPTH; NDC/UPC 17478071310; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 339 bottles | Class II | Terminated |
| D-0422-2021 | 03-15-2021 | BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM 4MG/1MG 30 POUCHES EACH CONTAINING 1 SUBLINGUAL FILM NDC/UPC 47781-0356-03; RX; FILM | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 249 CARTONS | Class II | Terminated |
| D-0411-2021 | 03-15-2021 | COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hydrochloride 22.3 mg/mL Timolol Maleate 6.8 mg/mL) 10ML Ocumeter Plus Ophthalmic Dispenser Sterile Ophthlamic Solution Rx only NDC/UPC 174780-605-10 Distributed by: Akorn, Inc. Lake Forest, IL 60045 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 12 bottles | Class II | Terminated |
| D-0533-2021 | 03-15-2021 | TOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENT | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 28 tubes | Class II | Terminated |
| D-0439-2021 | 03-15-2021 | AMOXICILLIN 500MG 100; NDC/UPC 65862001401; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 373 bottles | Class II | Terminated |
| D-0441-2021 | 03-15-2021 | ESZOPICLONE 3MG 100 C4; NDC/UPC 65862096901; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 29 bottles | Class II | Terminated |
| D-0488-2021 | 03-15-2021 | FaBB Vitamin B6 (as Pyridoxine Hydrochloride) 25 mg Folic Acid 2.2 mg Vitamin B12 (as Cyanocobalamin) 1.0 mg Dietary Supplement 100 Tablets Distributed by: H2-Pharma, LLC 2010 Berry Chase Place Montgomery, AL 36117 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 54 bottles | Class II | Terminated |
| D-0547-2021 | 03-15-2021 | LORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 2854 bottles | Class II | Terminated |
| D-0401-2021 | 03-15-2021 | NIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 4 bottles | Class II | Terminated |
| D-0452-2021 | 03-15-2021 | CATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 17 patches | Class II | Terminated |
| D-0560-2021 | 03-15-2021 | Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators Rx Only Manufactured for: Ednoceutics, Inc. Quebec City, Canada, G1V 4M7 Distributed by: AMAG Pharmaceuticals, Inc. Waltam, MA 02451, NDC 64011-601-28 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 205 cartons | Class II | Terminated |
| D-0539-2021 | 03-15-2021 | ZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 UNIT DOSE POUCHES; NDC/UPC 49884089911; RX; EACH POUCH CONTAINS ONE SUBLINGUAL TABLET | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 55 Boxes | Class II | Terminated |
| D-0532-2021 | 03-15-2021 | Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 Capsules NDC 75834-020-12 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 USA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 205 bottles | Class II | Terminated |
| D-0552-2021 | 03-15-2021 | LYRICA (pregabalin) capsules, 200mg 90-count bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, MADE IN SINGAPORE | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 49 bottles | Class II | Terminated |
| D-0445-2021 | 03-15-2021 | MURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 64 droptainers | Class II | Terminated |
| D-0475-2021 | 03-15-2021 | Prenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for Pregnant and Lactating Women UD 100 Tablets (10x10) NDC 77333-715-10 GenDose Pharmaceuticals | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Cardinal Health Inc. / 41 bottles | Class II | Terminated |
