D-0499-2021 | 03-15-2021 | 06-02-2021 | Class II | 136 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0449-2021 | 03-15-2021 | 06-02-2021 | Class II | 47 cartons | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0414-2021 | 03-15-2021 | 06-02-2021 | Class II | 72 tubes | Vaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only Net wt. 1.59 oz (45 g) Rx only NDC 0023-4857-45 Manufactured for Allegan, Inc. Irvine, CA 92612 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0437-2021 | 03-15-2021 | 06-02-2021 | Class II | 345 CARTONS | IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUSPENSION (NO DROPS) | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0535-2021 | 03-15-2021 | 06-02-2021 | Class II | 341 CARTON | 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. | Completed |
D-0407-2021 | 03-15-2021 | 06-02-2021 | Class II | 106 BOXES | FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0525-2021 | 03-15-2021 | 06-02-2021 | Class II | 122 inhalers | ASMANEX TWST 220MCG 60INH PWD; NDC/UPC 85134102; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0473-2021 | 03-15-2021 | 06-02-2021 | Class II | 11189 plungers | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0587-2021 | 03-15-2021 | 06-02-2021 | Class II | 31 cartons | Restora Omega-3 enhanced Lactobacillus Casei KE-99 30 Capsules 1 A Day Nutritional Supplement NDC 52747-200-30 Marketed by US Pharmaceutical Corporation, P.O. Box 360465, Decatur, GA 30036 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0450-2021 | 03-15-2021 | 06-02-2021 | Class II | 67 BOXES | SYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS; NDC 59385-041-30; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0586-2021 | 03-15-2021 | 06-02-2021 | Class II | 86 BOTTLE | TRAMADOL HYDROCHLORIDE TABLETS USP 100MG, 100-count bottle, Rx Only, Manufactured by: Rubicon Research :Private Limited, Ambernath, Dist. Thane, 421506 India, NDC: 52817-0196-10 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0494-2021 | 03-15-2021 | 06-02-2021 | Class II | 35 bags | Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) 24x100 mL Single Dose Flexible Containers NDC 0143-9721-24 West-Ward Pharmaceutical Corp Eatontown, NJ 07724 USA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0420-2021 | 03-15-2021 | 06-02-2021 | Class II | 759 bottles | Vraylar (cariprazine) capsules in all pack sizes, styles and strengths Rx only Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0432-2021 | 03-15-2021 | 06-02-2021 | Class II | 3 CARTON | GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0527-2021 | 03-15-2021 | 06-02-2021 | Class II | 72 cartons | 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. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0408-2021 | 03-15-2021 | 06-02-2021 | Class II | 339 bottles | OFLOXACIN 0.3% 5ML OPTH; NDC/UPC 17478071310; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0441-2021 | 03-15-2021 | 06-02-2021 | Class II | 29 bottles | ESZOPICLONE 3MG 100 C4; NDC/UPC 65862096901; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0488-2021 | 03-15-2021 | 06-02-2021 | Class II | 54 bottles | 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. | Completed |
D-0510-2021 | 03-15-2021 | 06-02-2021 | Class II | 91 CARTON | TRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET 10X10UD; NDC/UPC 0904-6868-61; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0439-2021 | 03-15-2021 | 06-02-2021 | Class II | 373 bottles | AMOXICILLIN 500MG 100; NDC/UPC 65862001401; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0579-2021 | 03-15-2021 | 06-02-2021 | Class II | 23 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0533-2021 | 03-15-2021 | 06-02-2021 | Class II | 28 tubes | TOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENT | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0422-2021 | 03-15-2021 | 06-02-2021 | Class II | 249 CARTONS | 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. | Completed |
D-0411-2021 | 03-15-2021 | 06-02-2021 | Class II | 12 bottles | 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. | Completed |
D-0434-2021 | 03-15-2021 | 06-02-2021 | Class II | 355 inhalers | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0547-2021 | 03-15-2021 | 06-02-2021 | Class II | 2854 bottles | LORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0568-2021 | 03-15-2021 | 06-02-2021 | Class II | 223 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0401-2021 | 03-15-2021 | 06-02-2021 | Class II | 4 bottles | NIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0452-2021 | 03-15-2021 | 06-02-2021 | Class II | 17 patches | CATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0560-2021 | 03-15-2021 | 06-02-2021 | Class II | 205 cartons | 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. | Completed |
D-0539-2021 | 03-15-2021 | 06-02-2021 | Class II | 55 Boxes | 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. | Completed |
D-0419-2021 | 03-15-2021 | 06-02-2021 | Class II | 31 tubes | Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only 30 g Rx Only NDC 58914-301-80 Mfd. by: Pharbil Waltrop GmbH, Im Wirrigen 25, 45731 Waltrop, Germany Distributed by: Aptalis Pharma US, Inc. Birmingham, AL 35242 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0532-2021 | 03-15-2021 | 06-02-2021 | Class II | 205 bottles | 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. | Completed |
D-0552-2021 | 03-15-2021 | 06-02-2021 | Class II | 49 bottles | 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. | Completed |
D-0491-2021 | 03-15-2021 | 06-02-2021 | Class II | 35 bottles | Calcium Acetate Capsules 667 mg 200 Capsules Rx only NDC 23155-531-02 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0475-2021 | 03-15-2021 | 06-02-2021 | Class II | 41 bottles | 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. | Completed |
D-0445-2021 | 03-15-2021 | 06-02-2021 | Class II | 64 droptainers | MURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0548-2021 | 03-15-2021 | 06-02-2021 | Class II | 1371 bottles | Cetirizine Hydrochloride Tablets, 10 mg, 300 Count; NDC/UPC 345802919878; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0403-2021 | 03-15-2021 | 06-02-2021 | Class II | 210 cartons | Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28 Tablets For 28 Days Rx only NDC 0074-0038-28 Each carton contains 28 tablets in 4 weekly blister pack, Each weekly blister pack contains 7 tablets of elagolix 150 mg AbbVie Inc. North Chicago, IL 60064 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0593-2021 | 03-15-2021 | 06-02-2021 | Class II | 35 BOTTLE | HALOPERIDOL TABLETS 20mg, USP, 100-count bottle, Rx Only Distributed by: Usher-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC: 0832-1560-11 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0404-2021 | 03-15-2021 | 06-02-2021 | Class II | 362 bottles | Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC 0074-3333-30 Abbott Laboratories North Chicago, IL 60064, U.S.A. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0503-2021 | 03-15-2021 | 06-02-2021 | Class II | 422 bottles | Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL (1 2/3 fl oz) Manufactrued by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0493-2021 | 03-15-2021 | 06-02-2021 | Class II | 12 bottles | LEUCOVORIN 15MG 24; NDC/UPC 54449810; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0470-2021 | 03-15-2021 | 06-02-2021 | Class II | 1 bottle | 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. | Completed |
D-0584-2021 | 03-15-2021 | 06-02-2021 | Class II | 37 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0443-2021 | 03-15-2021 | 06-02-2021 | Class II | 463 boxes | LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-07; RX; GEL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0504-2021 | 03-15-2021 | 06-02-2021 | Class II | 357 bottles | Ferrous Sulfate 75 mg (equivalent to 15 mg Iron) Per 1.0 mL Alcohol 0.2% v/v Drops Iron Supplement Drops For Infants and Toddlers 50 mL (1 2/3 fl oz) NDC 54838-011-50 Manufactured by: Silarx Pharmaceuticals, Inc. 19 West Street Spring Valley, NY 10977 USA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0501-2021 | 03-15-2021 | 06-02-2021 | Class II | 16 bottles | PHENTERMINE HCL 30MG 100 C4; NDC/UPC 10702002801; RX; CAPSULES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0474-2021 | 03-15-2021 | 06-02-2021 | Class II | 73 carton | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP 10-30-2MG/5ML 473ML; NDC/UPC 71930-026-43; RX; SYRUP | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0534-2021 | 03-15-2021 | 06-02-2021 | Class II | 348 droptainers | Ilevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile Rx Only NDC 0065-1750-14 Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0528-2021 | 03-15-2021 | 06-02-2021 | Class II | 620 injector | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0523-2021 | 03-15-2021 | 06-02-2021 | Class II | 299 cartons | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0569-2021 | 03-15-2021 | 06-02-2021 | Class II | 133 bottles | COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottle, Rx Only,/UPC 57664066683 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0511-2021 | 03-15-2021 | 06-02-2021 | Class II | 71 tubes | MICONAZOLE 7 2% 45GM APL; NDC/UPC 009047734459; OTC; CREAM | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0453-2021 | 03-15-2021 | 06-02-2021 | Class II | 2611 inhalers | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0537-2021 | 03-15-2021 | 06-02-2021 | Class II | 60 bottles | Benztropine Mesylate Tablets, USP in all pack sizes, styles and strengths Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0498-2021 | 03-15-2021 | 06-02-2021 | Class II | 534 syringes | INVEGA SUSTENNA 156MG/1ML; NDC/UPC 50458056301; RX; SYRINGES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0416-2021 | 03-15-2021 | 06-02-2021 | Class II | 3688 bottles | RESTASIS 0.05%30X 0.4ML OPTH PF; NDC/UPC 23916330; RX; DROPS/Restasis 0.05% 60x0.4 mL OPTH PF; NDC/UPC 23916330; RX | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0446-2021 | 03-15-2021 | 06-02-2021 | Class II | 47 droptainers | TOBRAMY/DEX 0.3-0.1% 10ML OPTH; NDC/UPC 24208029510; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0540-2021 | 03-15-2021 | 06-02-2021 | Class II | 236 bottles | HySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25 Manufactured in USA Patrin Pharma, Skokie, IL 60076 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0506-2021 | 03-15-2021 | 06-02-2021 | Class II | 4 bottles | Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only NDC 62175-180-46 Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0558-2021 | 03-15-2021 | 06-02-2021 | Class II | 49 CARTON | PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS), Rx Only, NDC 0211-0927-16 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0440-2021 | 03-15-2021 | 06-02-2021 | Class II | 1935 bottles | ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0456-2021 | 03-15-2021 | 06-02-2021 | Class II | 284 bottles | Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0168-69 Distributed by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0406-2021 | 03-15-2021 | 06-02-2021 | Class II | 51 bottles | METHOCARBAMOL 500MG 500; NDC/UPC 71093014005; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0515-2021 | 03-15-2021 | 06-02-2021 | Class II | 53 BOTTLE | VITAMIN D3 25MCG 90 TABLETS; NDC/UPC 880681168004; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0594-2021 | 03-15-2021 | 06-02-2021 | Class II | 2 bottles | Corgard (nadolol tablets, USP) 40 mg 100 Tablets Rx only NDC 27505-101-01 Distributed by US WorldMeds, LLC, Louisville, KY 40241 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0589-2021 | 03-15-2021 | 06-02-2021 | Class II | 796 bottles | VIMPAT(lacosamide) Tablets ,100 mg, 60-count bottle; Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0530-2021 | 03-15-2021 | 06-02-2021 | Class II | 47 bottles | NAT B VIT D3 2000U 100; NDC/UPC 079854041125; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0531-2021 | 03-15-2021 | 06-02-2021 | Class II | 523 bottles | Vitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 100 Capsules NDC 75834-020-01 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0461-2021 | 03-15-2021 | 06-02-2021 | Class II | 20 bottles | Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactured by: Jubilant Generics Ltd. Roorkee-247661, India | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0588-2021 | 03-15-2021 | 06-02-2021 | Class II | 32 bottles | INTEGRA 325/40/3mg 90-count bottle, NDC: 52747-710-60 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0465-2021 | 03-15-2021 | 06-02-2021 | Class II | 40 bags | CIPROFLOX/D5W 400/200 24X200ML; NDC/UPC 36000000924; RX; IV SOLUTION (PIGGYBACK) | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0444-2021 | 03-15-2021 | 06-02-2021 | Class II | 2 carton | BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM TOP EMOL NDC 187-0194--10; OTC; FOAMS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0454-2021 | 03-15-2021 | 06-02-2021 | Class II | 667 inhalers | ATROVENT HFA 17MCG 12.9GM; NDC/UPC 597008717; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0467-2021 | 03-15-2021 | 06-02-2021 | Class II | 1 bottle | Iron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-01 Distributed By: Cypress Pharmaceutical, Inc. 135 Industrial Blvd. Madison, MS 39110 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0497-2021 | 03-15-2021 | 06-02-2021 | Class II | 37 bottles | 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. | Completed |
D-0563-2021 | 03-15-2021 | 06-02-2021 | Class II | 148 syringes | medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-4538-02 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0542-2021 | 03-15-2021 | 06-02-2021 | Class II | 5 tubes | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0447-2021 | 03-15-2021 | 06-02-2021 | Class II | 318 droptainers | DEXAMETH SOD PHOS 0.1% 5ML; NDC/UPC 24208072002; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0502-2021 | 03-15-2021 | 06-02-2021 | Class II | 237 bottles | PHENTERMINE HCL 37.5MG 100 C4; NDC/UPC 10702002901; RX; CAPSULES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0574-2021 | 03-15-2021 | 06-02-2021 | Class II | 41 bottles | NEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC: 0093-1177-01 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0567-2021 | 03-15-2021 | 06-02-2021 | Class II | 1391 tubes | Collagenase Santyl Ointment 250 units/g 30 grams Rx Only Marketed by Smith & Nephew, Inc., Fort Worth, TX 76107, NDC 50484-010-30 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0522-2021 | 03-15-2021 | 06-02-2021 | Class II | 119 cartons | Belsomra (suvorexant) tablets 10 mg Each tablet contains 10 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets Rx only NDC 00006-0033-30 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0543-2021 | 03-15-2021 | 06-02-2021 | Class II | 31 bottles | Benzoyl Peroxide 10% Acne Medication Wash Net Wt 5 oz (142 g) Distributed By Perrigo Allegan, MI 49010, NDC 45802-318-01 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0400-2021 | 03-15-2021 | 06-02-2021 | Class II | 55 bottles | THERAPEUTIC M 130; NDC/UPC 740985223680; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0565-2021 | 03-15-2021 | 06-02-2021 | Class II | 143 tubes | HYDROCORTISONE 1% 30gm cream | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0463-2021 | 03-15-2021 | 06-02-2021 | Class II | 576 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0512-2021 | 03-15-2021 | 06-02-2021 | Class II | 88 bottles | Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60 Distributed by: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 USA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0487-2021 | 03-15-2021 | 06-02-2021 | Class II | 23 tubes | Hydrocortisone Ointment USP 1% Maximum Strength Net Wt. 1 oz (28 g) NDC 0472-0345-56 Manufactured by: Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28902 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0413-2021 | 03-15-2021 | 06-02-2021 | Class II | 152 CARTON | BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0541-2021 | 03-15-2021 | 06-02-2021 | Class II | 39 bottles | RISPERIDONE 1MG/ML 30ML; NDC/UPC 50458059601; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS) | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0476-2021 | 03-15-2021 | 06-02-2021 | Class II | 1473 vials | cathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 Genentech | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0521-2021 | 03-15-2021 | 06-02-2021 | Class II | 147 | PEDIA-LAX 66ML; NDC/UPC 301320202205; OTC; ENEMA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0557-2021 | 03-15-2021 | 06-02-2021 | Class II | 13 bottles | LEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfizer Inc., New York, NY 10017, MADE IN AUSTRIA, NDC: 60793-858-01 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0490-2021 | 03-15-2021 | 06-02-2021 | Class II | 122 bottles | AcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0415-2021 | 03-15-2021 | 06-02-2021 | Class II | 964 bottles | UBRELVY 100MG 10UD CPLT; NDC/UPC 23650110; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0597-2021 | 03-15-2021 | 06-02-2021 | Class II | 10 bottles | Enalapril Maleate Tablets, USP 2.5 mg 100 tablets Rx only Distributed by: Cardinal Health, NDC 64679-923-02 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0471-2021 | 03-15-2021 | 06-02-2021 | Class II | 504 cartons | Ivermectin Tablets USP 3 mg 20 Tablets (2 Foil Strips of 10 tablets each) Rx Only NDC 4799-806-01 Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054 877-381-3336 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0505-2021 | 03-15-2021 | 06-02-2021 | Class II | 78 bottles | SILADRYL 12.5/5ML 118ML SF AF; NDC/UPC 354838135404; OTC; LIQUID | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0492-2021 | 03-15-2021 | 06-02-2021 | Class II | 298 bottles | LITHIUM CARB 150MG 100; NDC/UPC 54252625; RX; CAPSULES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0544-2021 | 03-15-2021 | 06-02-2021 | Class II | 163 bottles | 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. | Completed |
D-0460-2021 | 03-15-2021 | 06-02-2021 | Class II | 3 bottles | PRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0519-2021 | 03-15-2021 | 06-02-2021 | Class II | 427 BOTTLE | VITAMIN D3 50MCG 100 CALC; NDC/UPC 880681170007; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0468-2021 | 03-15-2021 | 06-02-2021 | Class II | 75 bottles | BENICAR 40MG 30; NDC/UPC 65597010430; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0583-2021 | 03-15-2021 | 06-02-2021 | Class II | 52 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0477-2021 | 03-15-2021 | 06-02-2021 | Class II | 237 inhalers | FLOVENT DISKUS 100MCG 60; NDC/UPC 173060202; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0478-2021 | 03-15-2021 | 06-02-2021 | Class II | 297 inhalers | ADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0516-2021 | 03-15-2021 | 06-02-2021 | Class II | 19 BOTTLE | VITAMIN D3 25MCG 180 TABLETS; NDC/UPC 880681168011; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0596-2021 | 03-15-2021 | 06-02-2021 | Class II | 15 bottles | Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide Oral Syrup Net: 1 Pint (473 mL) Bulk Container-Not for Household Use Rx Only NDC 60432-275-16 Distributed By: Wockhardt USA, LLC Parsippany, NJ 07054 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0479-2021 | 03-15-2021 | 06-02-2021 | Class II | 513 inhalers | ARNUITY ELLIPTA 100MCG 30INH; NDC/UPC 173087410; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0409-2021 | 03-15-2021 | 06-02-2021 | Class II | 240 bottles | LIDOCAINE HCL VISC 2% 100ML; NDC/UPC 50383077504; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS) | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0405-2021 | 03-15-2021 | 06-02-2021 | Class II | 123 bottles | Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and concentrations Rx only Abbott Laboratories North Chicago, IL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0564-2021 | 03-15-2021 | 06-02-2021 | Class II | 8 vials | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0585-2021 | 03-15-2021 | 06-02-2021 | Class II | 80 bottles | Folivane-Plus with Ascorbic Acid Precursors Iron/Folic Acid/Vitamin Supplement Capsules 90 Capsules Rx Only NDC 13811-539-90 Manufactured for: Trigen Laboratories, Inc., Sayreville, NJ 08872 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0545-2021 | 03-15-2021 | 06-02-2021 | Class II | 934 boxes | 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. | Completed |
D-0546-2021 | 03-15-2021 | 06-02-2021 | Class II | 321 bottles | Fexofenadine Hydrochloride Tablets, 180 mg Antihistamine Non-Drowsy 100 Tablets 180 mg Each NDC 45802-571-78 Distributed By Perrigo Allegan, MI 49010 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0514-2021 | 03-15-2021 | 06-02-2021 | Class II | 380 BOTTLE | VITAMIN D3 50MCG 100 SOFTGELS; NDC/UPC 880681009000; OTC; GELCAP | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0559-2021 | 03-15-2021 | 06-02-2021 | Class II | 8 bottles | Nature's Truth Absorbable Calcium 1200 mg plus D3 5000 IU 120 Softgels Dietary Supplements Carefully Designed and Distributed by Nature's Truth LLC. Ronkonkoma, NY 11779, UPC 840093100672 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0426-2021 | 03-15-2021 | 06-02-2021 | Class II | 64 BOXES | 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. | Completed |
D-0592-2021 | 03-15-2021 | 06-02-2021 | Class II | 271 bottles | Amantadine Hydrochloride Tablets 100 mg 100-count bottle, Rx Only Manufactured by Upsher-Smith Laboratories, Inc. Maple Grove, MN 55369, NDC 0832-0111-00 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0438-2021 | 03-15-2021 | 06-02-2021 | Class II | 20 CARTONS | Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose Tablets Rx only NDC 59651-104-69 Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0591-2021 | 03-15-2021 | 06-02-2021 | Class II | 101 bottles | Briviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-570-66 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0572-2021 | 03-15-2021 | 06-02-2021 | Class II | 2907 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0562-2021 | 03-15-2021 | 06-02-2021 | Class II | 286 syringes | 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. | Completed |
D-0576-2021 | 03-15-2021 | 06-02-2021 | Class II | 91 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0526-2021 | 03-15-2021 | 06-02-2021 | Class II | 112 bottles | 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. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0556-2021 | 03-15-2021 | 06-02-2021 | Class II | 1040 cartons | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0517-2021 | 03-15-2021 | 06-02-2021 | Class II | 701 CARTON | DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL OINTMENT 28GM ; NDC/UPC 0536-1211-95; OTC; OINTMENT | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0448-2021 | 03-15-2021 | 06-02-2021 | Class II | 96 cartons | Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-023-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0495-2021 | 03-15-2021 | 06-02-2021 | Class II | 25 boxes | TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules; NDC/UPC 71858-0055-4; RX; CAPSULES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0524-2021 | 03-15-2021 | 06-02-2021 | Class II | 215 bottles | Steglatro (ertugliflozin) tablets 15 mg 30 Tablets Rx only NDC 0006-5364-03 Manuf. for: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ 08889, USA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0590-2021 | 03-15-2021 | 06-02-2021 | Class II | 882 bottles | VIMPAT (lacosamide) Tablets, 200mg, 60-count bottle, Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080, NDC 0131-2480-35 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0500-2021 | 03-15-2021 | 06-02-2021 | Class II | 453 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0536-2021 | 03-15-2021 | 06-02-2021 | Class II | 1189 cartons | Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 tablets 3 blister packs. Each pack contains 10 tablets. Rx only NDC 0169-4307-13 Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0507-2021 | 03-15-2021 | 06-02-2021 | Class II | 24 bottles | NOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz. (473 mL) NDC 68047-186-16 Distributed by: Larken Laboratories, Inc. Canton, MS 39046 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0508-2021 | 03-15-2021 | 06-02-2021 | Class II | 60 CARTON | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0417-2021 | 03-15-2021 | 06-02-2021 | Class II | 1529 bottles | Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-1203-30 Distributed by: Allergan USA, Inc. Irvine, CA 92612 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0577-2021 | 03-15-2021 | 06-02-2021 | Class II | 414 boxes | EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-5986-27 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0427-2021 | 03-15-2021 | 06-02-2021 | Class II | 38 bottles | Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles Rx Only NDC 60505-0813-1 Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0529-2021 | 03-15-2021 | 06-02-2021 | Class II | 834 aerosol containers | Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol 10 g net wt Rx Only NDC 0037-6822-10 Distributed by: Meda Pharmaceutical Inc. Somerset, New Jersey | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0472-2021 | 03-15-2021 | 06-02-2021 | Class II | 30 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0429-2021 | 03-15-2021 | 06-02-2021 | Class II | 328 bottles | Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0421-2021 | 03-15-2021 | 06-02-2021 | Class II | 15 bottles | Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-306-01 Manufactured by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 Distributed by: Alvogen, Inc. Parsippany, NJ 07054 U.S.A. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0423-2021 | 03-15-2021 | 06-02-2021 | Class II | 15885 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0442-2021 | 03-15-2021 | 06-02-2021 | Class II | 255 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0466-2021 | 03-15-2021 | 06-02-2021 | Class II | 13 packets | Prilosec (Omeprazole Magnesium) For Delayed-Release Oral Suspension 10 mg Rx only NDC 70515-610-01 Mfd. for: Covis Pharma, Zug, 6300 Switzerland | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0580-2021 | 03-15-2021 | 06-02-2021 | Class II | 828 inhalers | Levalbuterol tartrate HFA Inhalation Aerosol 45 mcg/actuation 200 Metered Inhalations Net Contents: 15 g Rx Only NDC 0591-2927-54 Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0428-2021 | 03-15-2021 | 06-02-2021 | Class II | 31 droptainers | 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. | Completed |
D-0555-2021 | 03-15-2021 | 06-02-2021 | Class II | 848 bottles | Chantix (varenicline) Tablets Continuing Month Box Contains: 4 Continuing Weeks (1 mg x 56 tablets) Rx only ; Rx only Distributed by Pfizer Labs Division of Pfizer, Inc., NY, NY ,10017NDC 0069-0469-56 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0554-2021 | 03-15-2021 | 06-02-2021 | Class II | 940 cartons | 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. | Completed |
D-0550-2021 | 03-15-2021 | 06-02-2021 | Class II | 95 suppositories | HYDROCORTISONE ACET 30MG 12; RX; SUPPOSITORY,Rx Only, Distributed by: Perrigo, Allegan, MI 49010, NDC: 0574-7093-12 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0480-2021 | 03-15-2021 | 06-02-2021 | Class II | 353 inhalers | Arnuity Ellipta (fluticasone furoate inhalation powder) 200 mcg 1 Ellipta Inhaler containing 1 Foil Strip of 30 Blisters Rx Only NDC 0173-0876-10 GlaxoSmithKline Research Triangle Park, NC 27709 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0553-2021 | 03-15-2021 | 06-02-2021 | Class II | 341 vials | 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. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0582-2021 | 03-15-2021 | 06-02-2021 | Class II | 92 bottles | Sulindac Tablets, USP, 200mg 100-count bottles, Rx Only, Manufactured by: Epic Pharma, LLC, Laurelton, NY 11413, NDC 42806-011-01 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0418-2021 | 03-15-2021 | 06-02-2021 | Class II | 659 bottles | Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10 mg per capsule 30 capsules Rx Only NDC 0456-1214-30 Distributed by Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, LLC. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0455-2021 | 03-15-2021 | 06-02-2021 | Class II | 592 bottles | Glyxambi (empagliflozin and linagliptin) Tablets 25 mg/5 mg 30 tablets Rx only NDC 0597-0164-30 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0458-2021 | 03-15-2021 | 06-02-2021 | Class II | 269 bottles | Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/1000 mg 30 tablets Rx only NDC 0597-0295-88 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0595-2021 | 03-15-2021 | 06-02-2021 | Class II | 6 boxes | CYANOCOBAL Injection 1000MCG/ML 25X1ML; NDC/UPC 69680-112-25; RX; MULTI DOSE VIAL | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0570-2021 | 03-15-2021 | 06-02-2021 | Class II | 490 bottles | 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. | Completed |
D-0425-2021 | 03-15-2021 | 06-02-2021 | Class II | 325 CARTONS | TRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML ; NDC/UPC 60505-0593-4; RX; DROPS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0424-2021 | 03-15-2021 | 06-02-2021 | Class II | 135 CARTON | ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0496-2021 | 03-15-2021 | 06-02-2021 | Class II | 11 bottles | 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. | Completed |
D-0431-2021 | 03-15-2021 | 06-02-2021 | Class II | 273 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0575-2021 | 03-15-2021 | 06-02-2021 | Class II | 235 bottles | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE TABLETS 2.5 mg/6.25 mg, 100-count bottles, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054 NDC 0093-3241-01 RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0483-2021 | 03-15-2021 | 06-02-2021 | Class II | 513 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0410-2021 | 03-15-2021 | 06-02-2021 | Class II | 424 bottles | Atropine Sulfate Ophthalmic Solution, USP 1% For Topical Application To The Eye Sterile 5 mL Rx only NDC 17478-215-05 Manufactured by: Akorn, Inc. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0462-2021 | 03-15-2021 | 06-02-2021 | Class II | 16 tubes | Sodium Sulfacetamide 9.8% & Sulfur 4.8% Cleanser (sodium sulfacetamide 9.8% and sulfur 4.8%) Net Wt. 10 oz. (285 g) Rx Only NDC 50096-502-10 Manufactured for: Rosemar Labs, LLC 2100 West Loop South Suite 900 Houston, TX 77027 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0571-2021 | 03-15-2021 | 06-02-2021 | Class II | 160 bottles | 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. | Completed |
D-0436-2021 | 03-15-2021 | 06-02-2021 | Class II | 378 bottles | xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets Rx only NDC 0310-6260-60 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0485-2021 | 03-15-2021 | 06-02-2021 | Class II | 141 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0566-2021 | 03-15-2021 | 06-02-2021 | Class II | 406 vials | Tuberculin Purified Protein Derivative (Mantous) TUBERSOL, Stabilized Solution 5 US Units, Rx Only Sanofi Pasteur Limited, NDC 49281-752-21 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0486-2021 | 03-15-2021 | 06-02-2021 | Class II | 2264 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0518-2021 | 03-15-2021 | 06-02-2021 | Class II | 37 BOTTLE | BENZOYL PEROXIDE WASH 5% 148ML; NDC/UPC 0536-1259-63; OTC; LIQUID | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0581-2021 | 03-15-2021 | 06-02-2021 | Class II | 57 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0538-2021 | 03-15-2021 | 06-02-2021 | Class II | 131 bottles | 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. | Completed |
D-0578-2021 | 03-15-2021 | 06-02-2021 | Class II | 1776 boxes | EPINEPHRINE INJECTION USP, 0.15 MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-5985-27 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0430-2021 | 03-15-2021 | 06-02-2021 | Class II | 244 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0489-2021 | 03-15-2021 | 06-02-2021 | Class II | 32 bottles | bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0573-2021 | 03-15-2021 | 06-02-2021 | Class II | 26895 inhalers | Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose Counter 200 Metered Inhalation 8,5 g Net Contents Rx only NDC 59310-579-22 Mktd by: Teva Respiratory, LLC Horsham, PA 19044 Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0513-2021 | 03-15-2021 | 06-02-2021 | Class II | 189 tubes | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0469-2021 | 03-15-2021 | 06-02-2021 | Class II | 6 CONTAINERS | PREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0482-2021 | 03-15-2021 | 06-02-2021 | Class II | 903 inhalers | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0402-2021 | 03-15-2021 | 06-02-2021 | Class II | 1669 bottles | 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. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0549-2021 | 03-15-2021 | 06-02-2021 | Class II | 180 bottles | Podofilox Topical Solution 0.5% 3.5ML, Rx Only, For Topical Use Only, Manufactured by Perrigo, Minneapolis, MN 55427, NDC 0574-0611-05. | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0484-2021 | 03-15-2021 | 06-02-2021 | Class II | 7 CARTON | EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0551-2021 | 03-15-2021 | 06-02-2021 | Class II | 178 tubes | Triamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: Perrigo, Allegan, MI 49010,NDC 45802-054-36 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0464-2021 | 03-15-2021 | 06-02-2021 | Class II | 40 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0509-2021 | 03-15-2021 | 06-02-2021 | Class II | 33 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0561-2021 | 03-15-2021 | 06-02-2021 | Class II | 905 inhalers | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0457-2021 | 03-15-2021 | 06-02-2021 | Class II | 52 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0481-2021 | 03-15-2021 | 06-02-2021 | Class II | 4065 CARTON | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0520-2021 | 03-15-2021 | 06-02-2021 | Class II | 407 BOXES | 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. | Completed |
D-0451-2021 | 03-15-2021 | 06-02-2021 | Class II | 1240 CARTON | NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAPID DISSOLUTION (NOT SUBLINGUAL) | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0412-2021 | 03-15-2021 | 06-02-2021 | Class II | 71 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0433-2021 | 03-15-2021 | 06-02-2021 | Class II | 1278 bottles | Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd. for: AstraZeneca LP, Wilmington, DE 19850 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0435-2021 | 03-15-2021 | 06-02-2021 | Class II | 664 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |
D-0459-2021 | 03-15-2021 | 06-02-2021 | Class II | 751 bottles | 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 | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Completed |