Recall Enforment Report D-0499-2021

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Cardinal Health Inc., originally initiated on 03-15-2021 for the product 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 The product was recalled due to cgmp deviations: intermittent exposure to temperature excursion during storage.. The product was distributed in Fl, Ga, Sc and the recall is currently completed.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0499-202103-15-202106-02-2021Class II136 bottlesAuryxia (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 USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0449-202103-15-202106-02-2021Class II47 cartonsBelbuca (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 USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0414-202103-15-202106-02-2021Class II72 tubesVaniqa (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 92612CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0437-202103-15-202106-02-2021Class II345 CARTONSIBUPROFEN 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-0535-202103-15-202106-02-2021Class II341 CARTONCIPRODEX (CIPROFLOXACIN 0.3 AND DEXAMETHASONE 0.1%) 7.5ML; NDC/UPC 0078-0799-75; RX; DROPSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0407-202103-15-202106-02-2021Class II106 BOXESFENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULESCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0525-202103-15-202106-02-2021Class II122 inhalersASMANEX TWST 220MCG 60INH PWD; NDC/UPC 85134102; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOLCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0473-202103-15-202106-02-2021Class II11189 plungersNarcan (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 USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0587-202103-15-202106-02-2021Class II31 cartonsRestora 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 30036CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0450-202103-15-202106-02-2021Class II67 BOXESSYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS; NDC 59385-041-30; RX; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0586-202103-15-202106-02-2021Class II86 BOTTLETRAMADOL HYDROCHLORIDE TABLETS USP 100MG, 100-count bottle, Rx Only, Manufactured by: Rubicon Research :Private Limited, Ambernath, Dist. Thane, 421506 India, NDC: 52817-0196-10CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0494-202103-15-202106-02-2021Class II35 bagsLevofloxacin 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 USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0420-202103-15-202106-02-2021Class II759 bottlesVraylar (cariprazine) capsules in all pack sizes, styles and strengths Rx only Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0432-202103-15-202106-02-2021Class II3 CARTONGEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIALCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0527-202103-15-202106-02-2021Class II72 cartonsEstradiol 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-0408-202103-15-202106-02-2021Class II339 bottlesOFLOXACIN 0.3% 5ML OPTH; NDC/UPC 17478071310; RX; DROPSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0441-202103-15-202106-02-2021Class II29 bottlesESZOPICLONE 3MG 100 C4; NDC/UPC 65862096901; RX; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0488-202103-15-202106-02-2021Class II54 bottlesFaBB 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 36117CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0510-202103-15-202106-02-2021Class II91 CARTONTRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET 10X10UD; NDC/UPC 0904-6868-61; RX; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0439-202103-15-202106-02-2021Class II373 bottlesAMOXICILLIN 500MG 100; NDC/UPC 65862001401; RX; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0579-202103-15-202106-02-2021Class II23 bottlesBalziva 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 0555-9034-58CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0533-202103-15-202106-02-2021Class II28 tubesTOBREX 0.3% 3.5GM OPTH; NDC/UPC 65064435; RX; OINTMENTCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0422-202103-15-202106-02-2021Class II249 CARTONSBUPRENORPHINE AND NALOXONE SUBLINGUAL FILM 4MG/1MG 30 POUCHES EACH CONTAINING 1 SUBLINGUAL FILM NDC/UPC 47781-0356-03; RX; FILMCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0411-202103-15-202106-02-2021Class II12 bottlesCOSOPT (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 60045CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0434-202103-15-202106-02-2021Class II355 inhalersBevespi 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 19850CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0547-202103-15-202106-02-2021Class II2854 bottlesLORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0568-202103-15-202106-02-2021Class II223 bottlesCLINDAMYCIN 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 63304-692-01CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0401-202103-15-202106-02-2021Class II4 bottlesNIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0452-202103-15-202106-02-2021Class II17 patchesCATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHESCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0560-202103-15-202106-02-2021Class II205 cartonsIntrarosa 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 64011-601-28CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0539-202103-15-202106-02-2021Class II55 BoxesZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 UNIT DOSE POUCHES; NDC/UPC 49884089911; RX; EACH POUCH CONTAINS ONE SUBLINGUAL TABLETCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0419-202103-15-202106-02-2021Class II31 tubesRectiv (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 35242CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0532-202103-15-202106-02-2021Class II205 bottlesVitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 12 Capsules NDC 75834-020-12 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0552-202103-15-202106-02-2021Class II49 bottlesLYRICA (pregabalin) capsules, 200mg 90-count bottle, Rx Only, Distributed by: Parke-Davis, Division of Pfizer Inc., NY, NY 10017, MADE IN SINGAPORECGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0491-202103-15-202106-02-2021Class II35 bottlesCalcium Acetate Capsules 667 mg 200 Capsules Rx only NDC 23155-531-02 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0475-202103-15-202106-02-2021Class II41 bottlesPrenatal Tablets Gluten Free Multivitamin/ Multimineral Dietary Supplement for Pregnant and Lactating Women UD 100 Tablets (10x10) NDC 77333-715-10 GenDose PharmaceuticalsCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0445-202103-15-202106-02-2021Class II64 droptainersMURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0548-202103-15-202106-02-2021Class II1371 bottlesCetirizine Hydrochloride Tablets, 10 mg, 300 Count; NDC/UPC 345802919878; OTC; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0403-202103-15-202106-02-2021Class II210 cartonsOrilissa 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 60064CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0593-202103-15-202106-02-2021Class II35 BOTTLEHALOPERIDOL TABLETS 20mg, USP, 100-count bottle, Rx Only Distributed by: Usher-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC: 0832-1560-11CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0404-202103-15-202106-02-2021Class II362 bottlesNorvir 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-0503-202103-15-202106-02-2021Class II422 bottlesInfants 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 USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0493-202103-15-202106-02-2021Class II12 bottlesLEUCOVORIN 15MG 24; NDC/UPC 54449810; RX; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0470-202103-15-202106-02-2021Class II1 bottlePhenobarbital Tablets, USP 32.4 mg 100 tablets Rx only NdC 13517-111-01 Manufactured for: e5 Pharma, LLC., Boca Raton, FL 33432CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0584-202103-15-202106-02-2021Class II37 bottlesDarifenacin 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 13668-203-30CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0443-202103-15-202106-02-2021Class II463 boxesLOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-07; RX; GELCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0504-202103-15-202106-02-2021Class II357 bottlesFerrous 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 USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0501-202103-15-202106-02-2021Class II16 bottlesPHENTERMINE HCL 30MG 100 C4; NDC/UPC 10702002801; RX; CAPSULESCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0474-202103-15-202106-02-2021Class II73 cartonBROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE SYRUP 10-30-2MG/5ML 473ML; NDC/UPC 71930-026-43; RX; SYRUPCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0534-202103-15-202106-02-2021Class II348 droptainersIlevro (nepafenac ophthalmic suspension) 0.3% 3 mL Sterile Rx Only NDC 0065-1750-14 Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0528-202103-15-202106-02-2021Class II620 injectorEpinephrine 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, 49502-501-01CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0523-202103-15-202106-02-2021Class II299 cartonsBelsomra (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, USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0569-202103-15-202106-02-2021Class II133 bottlesCOREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottle, Rx Only,/UPC 57664066683CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0511-202103-15-202106-02-2021Class II71 tubesMICONAZOLE 7 2% 45GM APL; NDC/UPC 009047734459; OTC; CREAMCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0453-202103-15-202106-02-2021Class II2611 inhalersSpiriva 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 USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0537-202103-15-202106-02-2021Class II60 bottlesBenztropine Mesylate Tablets, USP in all pack sizes, styles and strengths Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0498-202103-15-202106-02-2021Class II534 syringesINVEGA SUSTENNA 156MG/1ML; NDC/UPC 50458056301; RX; SYRINGESCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0416-202103-15-202106-02-2021Class II3688 bottlesRESTASIS 0.05%30X 0.4ML OPTH PF; NDC/UPC 23916330; RX; DROPS/Restasis 0.05% 60x0.4 mL OPTH PF; NDC/UPC 23916330; RXCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0446-202103-15-202106-02-2021Class II47 droptainersTOBRAMY/DEX 0.3-0.1% 10ML OPTH; NDC/UPC 24208029510; RX; DROPSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0540-202103-15-202106-02-2021Class II236 bottlesHySept Solution 0.25% Sodium Hypochlorite Solution 473 mL (16 fl. oz.) NDC 39328-063-25 Manufactured in USA Patrin Pharma, Skokie, IL 60076CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0506-202103-15-202106-02-2021Class II4 bottlesPantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only NDC 62175-180-46 Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0558-202103-15-202106-02-2021Class II49 CARTONPROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS), Rx Only, NDC 0211-0927-16CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0440-202103-15-202106-02-2021Class II1935 bottlesONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0456-202103-15-202106-02-2021Class II284 bottlesSynjardy (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 USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0406-202103-15-202106-02-2021Class II51 bottlesMETHOCARBAMOL 500MG 500; NDC/UPC 71093014005; RX; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0515-202103-15-202106-02-2021Class II53 BOTTLEVITAMIN D3 25MCG 90 TABLETS; NDC/UPC 880681168004; OTC; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0594-202103-15-202106-02-2021Class II2 bottlesCorgard (nadolol tablets, USP) 40 mg 100 Tablets Rx only NDC 27505-101-01 Distributed by US WorldMeds, LLC, Louisville, KY 40241CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0589-202103-15-202106-02-2021Class II796 bottlesVIMPAT(lacosamide) Tablets ,100 mg, 60-count bottle; Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0530-202103-15-202106-02-2021Class II47 bottlesNAT B VIT D3 2000U 100; NDC/UPC 079854041125; OTC; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0531-202103-15-202106-02-2021Class II523 bottlesVitamin D3 Cholecalciferol 50,000 IU Dietary Supplement 100 Capsules NDC 75834-020-01 Marketed by: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0461-202103-15-202106-02-2021Class II20 bottlesValsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC 59746-360-30 Manufactured by: Jubilant Generics Ltd. Roorkee-247661, IndiaCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0588-202103-15-202106-02-2021Class II32 bottlesINTEGRA 325/40/3mg 90-count bottle, NDC: 52747-710-60CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0465-202103-15-202106-02-2021Class II40 bagsCIPROFLOX/D5W 400/200 24X200ML; NDC/UPC 36000000924; RX; IV SOLUTION (PIGGYBACK)CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0444-202103-15-202106-02-2021Class II2 cartonBENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM TOP EMOL NDC 187-0194--10; OTC; FOAMSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0454-202103-15-202106-02-2021Class II667 inhalersATROVENT HFA 17MCG 12.9GM; NDC/UPC 597008717; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOLCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0467-202103-15-202106-02-2021Class II1 bottleIron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-01 Distributed By: Cypress Pharmaceutical, Inc. 135 Industrial Blvd. Madison, MS 39110CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0497-202103-15-202106-02-2021Class II37 bottlesTylenol Acetaminophen Pain Regular Strength Liquid Gels Pain Reliever Fever Reducer 20 Liquid Gels 325 mg each NDC 50580-487-20CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0563-202103-15-202106-02-2021Class II148 syringesmedroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Only, Distributed by: Greenstone LLC, Peapack, NJ 07977, NDC 59762-4538-02CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0542-202103-15-202106-02-2021Class II5 tubesBenzoyl Peroxide 2.5% Aqueous Base, Acne Treatment Gel Net Wt. 2.1 oz (60 g) NDC 45802-101-96 Distributed By Perrigo Allegan, MI 49010CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0447-202103-15-202106-02-2021Class II318 droptainersDEXAMETH SOD PHOS 0.1% 5ML; NDC/UPC 24208072002; RX; DROPSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0502-202103-15-202106-02-2021Class II237 bottlesPHENTERMINE HCL 37.5MG 100 C4; NDC/UPC 10702002901; RX; CAPSULESCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0574-202103-15-202106-02-2021Class II41 bottlesNEOMYCIN SULF TABLETS, USP, 500mg, 100-count bottle, Rx Only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC: 0093-1177-01CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0567-202103-15-202106-02-2021Class II1391 tubesCollagenase Santyl Ointment 250 units/g 30 grams Rx Only Marketed by Smith & Nephew, Inc., Fort Worth, TX 76107, NDC 50484-010-30CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0522-202103-15-202106-02-2021Class II119 cartonsBelsomra (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, USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0543-202103-15-202106-02-2021Class II31 bottlesBenzoyl Peroxide 10% Acne Medication Wash Net Wt 5 oz (142 g) Distributed By Perrigo Allegan, MI 49010, NDC 45802-318-01CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0400-202103-15-202106-02-2021Class II55 bottlesTHERAPEUTIC M 130; NDC/UPC 740985223680; OTC; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0565-202103-15-202106-02-2021Class II143 tubesHYDROCORTISONE 1% 30gm creamCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0463-202103-15-202106-02-2021Class II576 bottlesMeloxicam 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 33156CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0512-202103-15-202106-02-2021Class II88 bottlesBanophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60 Distributed by: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0487-202103-15-202106-02-2021Class II23 tubesHydrocortisone 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 28902CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0413-202103-15-202106-02-2021Class II152 CARTONBROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0541-202103-15-202106-02-2021Class II39 bottlesRISPERIDONE 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-0476-202103-15-202106-02-2021Class II1473 vialscathflo activase (ALTEPLASE) 2 mg Rx Only NDC 50242-041-64 GenentechCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0521-202103-15-202106-02-2021Class II147PEDIA-LAX 66ML; NDC/UPC 301320202205; OTC; ENEMACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0557-202103-15-202106-02-2021Class II13 bottlesLEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfizer Inc., New York, NY 10017, MADE IN AUSTRIA, NDC: 60793-858-01CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0490-202103-15-202106-02-2021Class II122 bottlesAcetaZOLAMIDE Tablets, USP 125 mg 100 Tablets Rx only NDC 23155-287-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0415-202103-15-202106-02-2021Class II964 bottlesUBRELVY 100MG 10UD CPLT; NDC/UPC 23650110; RX; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0597-202103-15-202106-02-2021Class II10 bottlesEnalapril Maleate Tablets, USP 2.5 mg 100 tablets Rx only Distributed by: Cardinal Health, NDC 64679-923-02CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0471-202103-15-202106-02-2021Class II504 cartonsIvermectin 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 877-381-3336CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0505-202103-15-202106-02-2021Class II78 bottlesSILADRYL 12.5/5ML 118ML SF AF; NDC/UPC 354838135404; OTC; LIQUIDCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0492-202103-15-202106-02-2021Class II298 bottlesLITHIUM CARB 150MG 100; NDC/UPC 54252625; RX; CAPSULESCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0544-202103-15-202106-02-2021Class II163 bottlesPolyethylene 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 49010CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0460-202103-15-202106-02-2021Class II3 bottlesPRAVACHOL 40MG 90; NDC/UPC 3519410; RX; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0519-202103-15-202106-02-2021Class II427 BOTTLEVITAMIN D3 50MCG 100 CALC; NDC/UPC 880681170007; OTC; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0468-202103-15-202106-02-2021Class II75 bottlesBENICAR 40MG 30; NDC/UPC 65597010430; RX; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0583-202103-15-202106-02-2021Class II52 bottlesDarifenacin 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 13668-202-30CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0477-202103-15-202106-02-2021Class II237 inhalersFLOVENT DISKUS 100MCG 60; NDC/UPC 173060202; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOLCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0478-202103-15-202106-02-2021Class II297 inhalersADVAIR HFA 45-21MCG 12GM; NDC/UPC 173071520; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOLCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0516-202103-15-202106-02-2021Class II19 BOTTLEVITAMIN D3 25MCG 180 TABLETS; NDC/UPC 880681168011; OTC; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0596-202103-15-202106-02-2021Class II15 bottlesBrompheniramine 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 07054CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0479-202103-15-202106-02-2021Class II513 inhalersARNUITY ELLIPTA 100MCG 30INH; NDC/UPC 173087410; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOLCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0409-202103-15-202106-02-2021Class II240 bottlesLIDOCAINE 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-0405-202103-15-202106-02-2021Class II123 bottlesSynthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and concentrations Rx only Abbott Laboratories North Chicago, ILCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0564-202103-15-202106-02-2021Class II8 vialsCefazolin 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 0781-3451-70CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0585-202103-15-202106-02-2021Class II80 bottlesFolivane-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 08872CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0545-202103-15-202106-02-2021Class II934 boxesPOLYETHYLENE GLYCOL 3350 Powder for Solution Osmotic Laxative 14 once-daily doses 14 Packet- Newt Wt. 0.5 oz (17g) each NDC 45802-868-66CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0546-202103-15-202106-02-2021Class II321 bottlesFexofenadine Hydrochloride Tablets, 180 mg Antihistamine Non-Drowsy 100 Tablets 180 mg Each NDC 45802-571-78 Distributed By Perrigo Allegan, MI 49010CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0514-202103-15-202106-02-2021Class II380 BOTTLEVITAMIN D3 50MCG 100 SOFTGELS; NDC/UPC 880681009000; OTC; GELCAPCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0559-202103-15-202106-02-2021Class II8 bottlesNature'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 840093100672CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0426-202103-15-202106-02-2021Class II64 BOXESENOXAPARIN DOFIUM INJRVYION, UPD 150MG/1ML 10X1ML SINGLE DOSE SYRINGES; NDC/UPC 60505-0798-4; RX; SYRINGESCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0592-202103-15-202106-02-2021Class II271 bottlesAmantadine Hydrochloride Tablets 100 mg 100-count bottle, Rx Only Manufactured by Upsher-Smith Laboratories, Inc. Maple Grove, MN 55369, NDC 0832-0111-00CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0438-202103-15-202106-02-2021Class II20 CARTONSEletriptan 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 08520CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0591-202103-15-202106-02-2021Class II101 bottlesBriviact (brivaracetam) tablets 50 mg, 60-count bottle, Rx only Manufactured for UCB, Inc. Smyrna, GA 30080, NDC 50474-570-66CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0572-202103-15-202106-02-2021Class II2907 bottlesChildren'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 10532CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0562-202103-15-202106-02-2021Class II286 syringesMedroxyprogesterone acetate injectable suspension, USP 150 mg per mL 1 mL Prefilled Syringe Rx only NDC 59762-4538-2 Distributed by: Greenstone, LLC. Peapack, NJ 07977CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0576-202103-15-202106-02-2021Class II91 bottlesPENICILLIN V POT for Oral Solution, USP 125mg/5mL 100mL (when mixed) Rx Only, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4125-73CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0526-202103-15-202106-02-2021Class II112 bottlesLevothyroxine 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-0556-202103-15-202106-02-2021Class II1040 cartonsChantix (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 10017CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0517-202103-15-202106-02-2021Class II701 CARTONDIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL OINTMENT 28GM ; NDC/UPC 0536-1211-95; OTC; OINTMENTCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0448-202103-15-202106-02-2021Class II96 cartonsBelbuca (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-0495-202103-15-202106-02-2021Class II25 boxesTIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules; NDC/UPC 71858-0055-4; RX; CAPSULESCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0524-202103-15-202106-02-2021Class II215 bottlesSteglatro (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, USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0590-202103-15-202106-02-2021Class II882 bottlesVIMPAT (lacosamide) Tablets, 200mg, 60-count bottle, Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080, NDC 0131-2480-35CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0500-202103-15-202106-02-2021Class II453 bottlesLivalo (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 JapanCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0536-202103-15-202106-02-2021Class II1189 cartonsRybelsus (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, DenmarkCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0507-202103-15-202106-02-2021Class II24 bottlesNOHIST-DM Antihistamine/Antitussive Nasal Decongestant 16 fl. oz. (473 mL) NDC 68047-186-16 Distributed by: Larken Laboratories, Inc. Canton, MS 39046CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0508-202103-15-202106-02-2021Class II60 CARTONTRI-LO-MARZIA 0.180MG/0.025MG; 0.215 MG/0.025MG AND 0.250MG/0.025MG 3X28 BPK; NDC/UPC 68180-837-73; RX; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0417-202103-15-202106-02-2021Class II1529 bottlesLinzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-1203-30 Distributed by: Allergan USA, Inc. Irvine, CA 92612CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0577-202103-15-202106-02-2021Class II414 boxesEPINEPHRINE 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 0093-5986-27CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0427-202103-15-202106-02-2021Class II38 bottlesButorphanol 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 1T9CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0529-202103-15-202106-02-2021Class II834 aerosol containersProctofoam 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 JerseyCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0472-202103-15-202106-02-2021Class II30 bottlesBanzel (rufinamide) tablets 200 mg 120 tablets Rx only NDC 62856-582-52 Manufactured by Eisai Co., Ltd. Marketed by Eisai Inc. Woodcliff Lake, NJ 07677CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0429-202103-15-202106-02-2021Class II328 bottlesEdarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0421-202103-15-202106-02-2021Class II15 bottlesNitrofurantoin 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-0423-202103-15-202106-02-2021Class II15885 bottlesOseltamivir 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 USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0442-202103-15-202106-02-2021Class II255 bottlesNuedexta (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, CanadaCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0466-202103-15-202106-02-2021Class II13 packetsPrilosec (Omeprazole Magnesium) For Delayed-Release Oral Suspension 10 mg Rx only NDC 70515-610-01 Mfd. for: Covis Pharma, Zug, 6300 SwitzerlandCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0580-202103-15-202106-02-2021Class II828 inhalersLevalbuterol 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 USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0428-202103-15-202106-02-2021Class II31 droptainersTimolol 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 33326CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0555-202103-15-202106-02-2021Class II848 bottlesChantix (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 0069-0469-56CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0554-202103-15-202106-02-2021Class II940 cartonsChantix (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 10017CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0550-202103-15-202106-02-2021Class II95 suppositoriesHYDROCORTISONE ACET 30MG 12; RX; SUPPOSITORY,Rx Only, Distributed by: Perrigo, Allegan, MI 49010, NDC: 0574-7093-12CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0480-202103-15-202106-02-2021Class II353 inhalersArnuity 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 27709CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0553-202103-15-202106-02-2021Class II341 vialsMethotrexate 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-0582-202103-15-202106-02-2021Class II92 bottlesSulindac Tablets, USP, 200mg 100-count bottles, Rx Only, Manufactured by: Epic Pharma, LLC, Laurelton, NY 11413, NDC 42806-011-01CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0418-202103-15-202106-02-2021Class II659 bottlesNamzaric (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-0455-202103-15-202106-02-2021Class II592 bottlesGlyxambi (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 USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0458-202103-15-202106-02-2021Class II269 bottlesSynjardy 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 USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0595-202103-15-202106-02-2021Class II6 boxesCYANOCOBAL Injection 1000MCG/ML 25X1ML; NDC/UPC 69680-112-25; RX; MULTI DOSE VIALCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0570-202103-15-202106-02-2021Class II490 bottlesTrokendi 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 17772-103-30CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0425-202103-15-202106-02-2021Class II325 CARTONSTRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML ; NDC/UPC 60505-0593-4; RX; DROPSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0424-202103-15-202106-02-2021Class II135 CARTONERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0496-202103-15-202106-02-2021Class II11 bottlesEnbrace HR 30 ct. Softgels Enhanced Prenatal Vitamin Supplement Rx NDC 64661-650-30 Manufactured for: JAYMAC Pharmaceuticals, LLC, Sunset, LA 70584CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0431-202103-15-202106-02-2021Class II273 bottlesedarbyclor 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 30328CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0575-202103-15-202106-02-2021Class II235 bottlesBISOPROLOL 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; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0483-202103-15-202106-02-2021Class II513 bottlesVerapamil 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 07430CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0410-202103-15-202106-02-2021Class II424 bottlesAtropine 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-0462-202103-15-202106-02-2021Class II16 tubesSodium 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 77027CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0571-202103-15-202106-02-2021Class II160 bottlesColcrys (colchicine, USP) tablets 0.6 mg 30 tablets Rx only Distributed by: Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015,NDC 64764-119-07CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0436-202103-15-202106-02-2021Class II378 bottlesxigduo 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 19850CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0485-202103-15-202106-02-2021Class II141 bottlesTheophylline (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 07430CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0566-202103-15-202106-02-2021Class II406 vialsTuberculin Purified Protein Derivative (Mantous) TUBERSOL, Stabilized Solution 5 US Units, Rx Only Sanofi Pasteur Limited, NDC 49281-752-21CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0486-202103-15-202106-02-2021Class II2264 bottlesTriumeq (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 27709CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0518-202103-15-202106-02-2021Class II37 BOTTLEBENZOYL PEROXIDE WASH 5% 148ML; NDC/UPC 0536-1259-63; OTC; LIQUIDCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0581-202103-15-202106-02-2021Class II57 bottlesDesvenlafaxine 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 USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0538-202103-15-202106-02-2021Class II131 bottlesLamotrigine 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-0578-202103-15-202106-02-2021Class II1776 boxesEPINEPHRINE 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 0093-5985-27CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0430-202103-15-202106-02-2021Class II244 bottlesedarbyclor 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 30328CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0489-202103-15-202106-02-2021Class II32 bottlesbupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0573-202103-15-202106-02-2021Class II26895 inhalersProair 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, IrelandCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0513-202103-15-202106-02-2021Class II189 tubesAcne 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 48150CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0469-202103-15-202106-02-2021Class II6 CONTAINERSPREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULESCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0482-202103-15-202106-02-2021Class II903 inhalersTrelegy 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 27709CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0402-202103-15-202106-02-2021Class II1669 bottlesCreon (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-0549-202103-15-202106-02-2021Class II180 bottlesPodofilox 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-0484-202103-15-202106-02-2021Class II7 CARTONEZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0551-202103-15-202106-02-2021Class II178 tubesTriamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: Perrigo, Allegan, MI 49010,NDC 45802-054-36CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0464-202103-15-202106-02-2021Class II40 bottlesNadolol 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 33156CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0509-202103-15-202106-02-2021Class II33 bottlesAmlodipine 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, IndiaCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0561-202103-15-202106-02-2021Class II905 inhalersBudesonide 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 0310-7372-20CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0457-202103-15-202106-02-2021Class II52 bottlesJentadueto 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 USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0481-202103-15-202106-02-2021Class II4065 CARTONTRELEGY 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 AEROSOLCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0520-202103-15-202106-02-2021Class II407 BOXESCARBIDOPA AND LEVORDOPA TABLETS, USP 25MG/100MG 100 TABLETS; NDC/UPC 51862-856-01; RX; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0451-202103-15-202106-02-2021Class II1240 CARTONNURTEC 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-0412-202103-15-202106-02-2021Class II71 bottlesMetoprolol 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 USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0433-202103-15-202106-02-2021Class II1278 bottlesBrilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd. for: AstraZeneca LP, Wilmington, DE 19850CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0435-202103-15-202106-02-2021Class II664 bottlesxigduo 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 00791CGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed
D-0459-202103-15-202106-02-2021Class II751 bottlesSynjardy 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 USACGMP Deviations: Intermittent exposure to temperature excursion during storage.Completed

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0006-0005Belsomra SuvorexantTablet, Film CoatedOralMerck Sharp & Dohme LlcHuman Prescription Drug
0006-0033Belsomra SuvorexantTablet, Film CoatedOralMerck Sharp & Dohme LlcHuman Prescription Drug
0006-0325Belsomra SuvorexantTablet, Film CoatedOralMerck Sharp & Dohme LlcHuman Prescription Drug
0006-0335Belsomra SuvorexantTablet, Film CoatedOralMerck Sharp & Dohme LlcHuman Prescription Drug
0006-5363Steglatro ErtugliflozinTablet, Film CoatedOralMerck Sharp & Dohme LlcHuman Prescription Drug
0006-5364Steglatro ErtugliflozinTablet, Film CoatedOralMerck Sharp & Dohme LlcHuman Prescription Drug
0032-0045Creon PancrelipaseCapsule, Delayed ReleaseOralAbbvie Inc.Human Prescription Drug
0032-0046Creon PancrelipaseCapsule, Delayed Release PelletsOralAbbvie Inc.Human Prescription Drug
0032-0047Creon PancrelipaseCapsule, Delayed Release PelletsOralAbbvie Inc.Human Prescription Drug
0032-1203Creon PancrelipaseCapsule, Delayed ReleaseOralAbbvie Inc.Human Prescription Drug
0032-1206Creon PancrelipaseCapsule, Delayed Release PelletsOralAbbvie Inc.Human Prescription Drug
0032-1212Creon PancrelipaseCapsule, Delayed Release PelletsOralAbbvie Inc.Human Prescription Drug
0032-1224Creon PancrelipaseCapsule, Delayed Release PelletsOralAbbvie Inc.Human Prescription Drug
0032-2636Creon PancrelipaseCapsule, Delayed Release PelletsOralAbbvie Inc.Human Prescription Drug
0032-2637Creon PancrelipaseCapsule, Delayed Release PelletsOralAbbvie Inc.Human Prescription Drug
0032-3016Creon PancrelipaseCapsule, Delayed Release PelletsOralAbbvie Inc.Human Prescription Drug
0037-6822Proctofoam HCPramoxine Hydrochloride Hydrocortisone AcetateAerosol, FoamTopicalMeda Pharmaceuticals Inc.Human Prescription Drug
0069-0468Chantix Varenicline TartrateTablet, Film CoatedOralPfizer Laboratories Div Pfizer IncHuman Prescription Drug
0069-0469Chantix Varenicline TartrateTablet, Film CoatedOralPfizer Laboratories Div Pfizer IncHuman Prescription Drug
0069-0471Chantix Varenicline TartrateKitPfizer Laboratories Div Pfizer IncHuman Prescription Drug
0074-0038Orilissa ElagolixTablet, Film CoatedOralAbbvie Inc.Human Prescription Drug
0074-0039Orilissa ElagolixTablet, Film CoatedOralAbbvie Inc.Human Prescription Drug
0074-2340Norvir RitonavirTablet, Film CoatedOralAbbvie Inc.Human Prescription Drug
0074-3399Norvir RitonavirPowderOralAbbvie Inc.Human Prescription Drug
0078-0799Ciprodex Ciprofloxacin And DexamethasoneSuspension/ DropsAuricular (otic)Novartis Pharmaceuticals CorporationHuman Prescription Drug
0093-1172Penicillin V Potassium Penicillin V PotassiumTabletOralTeva Pharmaceuticals Usa, Inc.Human Prescription Drug
0093-1174Penicillin V Potassium Penicillin V PotassiumTabletOralTeva Pharmaceuticals Usa, Inc.Human Prescription Drug
0093-1177Neomycin Sulfate Neomycin SulfateTabletOralTeva Pharmaceuticals Usa, Inc.Human Prescription Drug
0093-3241 Bisoprolol Fumarate And HydrochlorothiazideTablet, Film CoatedTeva Pharmaceuticals Usa, Inc.Bulk Ingredient
0093-3241Bisoprolol Fumarate And Hydrochlorothiazide Bisoprolol Fumarate And HydrochlorothiazideTablet, Film CoatedOralTeva Pharmaceuticals Usa, Inc.Human Prescription Drug
0093-3242 Bisoprolol Fumarate And HydrochlorothiazideTablet, Film CoatedTeva Pharmaceuticals Usa, Inc.Bulk Ingredient
0093-3242Bisoprolol Fumarate And Hydrochlorothiazide Bisoprolol Fumarate And HydrochlorothiazideTablet, Film CoatedOralTeva Pharmaceuticals Usa, Inc.Human Prescription Drug
0093-3243 Bisoprolol Fumarate And HydrochlorothiazideTablet, Film CoatedTeva Pharmaceuticals Usa, Inc.Bulk Ingredient
0093-3243Bisoprolol Fumarate And Hydrochlorothiazide Bisoprolol Fumarate And HydrochlorothiazideTablet, Film CoatedOralTeva Pharmaceuticals Usa, Inc.Human Prescription Drug
0093-4125Penicillin V Potassium Penicillin V PotassiumPowder, For SolutionOralTeva Pharmaceuticals Usa, Inc.Human Prescription Drug
0093-4127Penicillin V Potassium Penicillin V PotassiumPowder, For SolutionOralTeva Pharmaceuticals Usa, Inc.Human Prescription Drug
0093-5985 EpinephrineInjectionTeva Pharmaceuticals Usa, Inc.Drug For Further Processing
0093-5985Epinephrine EpinephrineInjectionIntramuscular; SubcutaneousTeva Pharmaceuticals Usa, Inc.Human Prescription Drug
0093-5986 EpinephrineInjectionTeva Pharmaceuticals Usa, Inc.Drug For Further Processing
0093-5986Epinephrine EpinephrineInjectionIntramuscular; SubcutaneousTeva Pharmaceuticals Usa, Inc.Human Prescription Drug
0131-1810Vimpat LacosamideInjectionIntravenousUcb, Inc.Human Prescription Drug
0131-2477Vimpat LacosamideTablet, Film CoatedOralUcb, Inc.Human Prescription Drug
0131-2478Vimpat LacosamideTablet, Film CoatedOralUcb, Inc.Human Prescription Drug
0131-2479Vimpat LacosamideTablet, Film CoatedOralUcb, Inc.Human Prescription Drug
0131-2480Vimpat LacosamideTablet, Film CoatedOralUcb, Inc.Human Prescription Drug
0131-5410Vimpat LacosamideSolutionOralUcb, Inc.Human Prescription Drug
0143-9720Levofloxacin LevofloxacinInjection, SolutionIntravenousHikma Pharmaceuticals Usa Inc.Human Prescription Drug
0143-9721Levofloxacin LevofloxacinInjection, SolutionIntravenousHikma Pharmaceuticals Usa Inc.Human Prescription Drug
0143-9722Levofloxacin LevofloxacinInjection, SolutionIntravenousHikma Pharmaceuticals Usa Inc.Human Prescription Drug
0169-4303Rybelsus Oral SemaglutideTabletOralNovo NordiskHuman Prescription Drug
0169-4307Rybelsus Oral SemaglutideTabletOralNovo NordiskHuman Prescription Drug
0169-4314Rybelsus Oral SemaglutideTabletOralNovo NordiskHuman Prescription Drug
0173-0874Arnuity Ellipta Fluticasone FuroatePowderRespiratory (inhalation)Glaxosmithkline LlcHuman Prescription Drug
0173-0876Arnuity Ellipta Fluticasone FuroatePowderRespiratory (inhalation)Glaxosmithkline LlcHuman Prescription Drug
0173-0887Trelegy Ellipta Fluticasone Furoate, Umeclidinium Bromide And Vilanterol TrifenatatePowderRespiratory (inhalation)Glaxosmithkline LlcHuman Prescription Drug
0173-0888Arnuity Ellipta Fluticasone FuroatePowderRespiratory (inhalation)Glaxosmithkline LlcHuman Prescription Drug
0173-0893Trelegy Ellipta Fluticasone Furoate, Umeclidinium Bromide And Vilanterol TrifenatatePowderRespiratory (inhalation)Glaxosmithkline LlcHuman Prescription Drug
0186-0776Brilinta TicagrelorTabletOralAstrazeneca Pharmaceuticals LpHuman Prescription Drug
0186-0777Brilinta TicagrelorTabletOralAstrazeneca Pharmaceuticals LpHuman Prescription Drug
0310-4600Bevespi Aerosphere Glycopyrrolate And Formoterol FumarateAerosol, MeteredRespiratory (inhalation)Astrazeneca Pharmaceuticals LpHuman Prescription Drug
0310-7370Budesonide And Formoterol Fumarate Dihydrate Budesonide And Formoterol Fumarate DihydrateAerosolRespiratory (inhalation)Astrazeneca Pharmaceuticals LpHuman Prescription Drug
0310-7372Budesonide And Formoterol Fumarate Dihydrate Budesonide And Formoterol Fumarate DihydrateAerosolRespiratory (inhalation)Astrazeneca Pharmaceuticals LpHuman Prescription Drug
0378-1800Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-1803Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-1805Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-1807Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-1809Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-1811Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-1813Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-1815Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-1817Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-1819Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-1821Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-1823Levothyroxine Sodium Levothyroxine SodiumTabletOralMylan Pharmaceuticals Inc.Human Prescription Drug
0378-4619Estradiol EstradiolPatchTransdermalMylan Pharmaceuticals Inc.Human Prescription Drug
0378-4620Estradiol EstradiolPatchTransdermalMylan Pharmaceuticals Inc.Human Prescription Drug
0378-4621Estradiol EstradiolPatchTransdermalMylan Pharmaceuticals Inc.Human Prescription Drug
0378-4622Estradiol EstradiolPatchTransdermalMylan Pharmaceuticals Inc.Human Prescription Drug
0378-4623Estradiol EstradiolPatchTransdermalMylan Pharmaceuticals Inc.Human Prescription Drug
0456-1201Linzess LinaclotideCapsule, Gelatin CoatedOralAllergan, Inc.Human Prescription Drug
0456-1202Linzess LinaclotideCapsule, Gelatin CoatedOralAllergan, Inc.Human Prescription Drug
0456-1203Linzess LinaclotideCapsule, Gelatin CoatedOralAllergan, Inc.Human Prescription Drug
0456-1207Namzaric Memantine Hydrochloride And Donepezil HydrochlorideCapsuleOralAllergan, Inc.Human Prescription Drug
0456-1214Namzaric Memantine Hydrochloride And Donepezil HydrochlorideCapsuleOralAllergan, Inc.Human Prescription Drug
0456-1221Namzaric Memantine Hydrochloride And Donepezil HydrochlorideCapsuleOralAllergan, Inc.Human Prescription Drug
0456-1228Namzaric Memantine Hydrochloride And Donepezil HydrochlorideCapsuleOralAllergan, Inc.Human Prescription Drug
0456-1229Namzaric Memantine Hydrochloride And Donepezil HydrochlorideKitOralAllergan, Inc.Human Prescription Drug
0536-1055Rugby Benzoyl Peroxide Acne MedicationBenzoyl PeroxideGelTopicalRugby Laboratories, Inc.Human Otc Drug
0536-1211Dibucaine Topical Anesthetic 1% Hemorrhoidal DibucaineOintmentTopicalRugby Laboratories Inc.Human Otc Drug
0536-1259Rugby Benzoyl Peroxide Wash Acne MedicationBenzoyl PeroxideLotionTopicalRugby LaboratoriesHuman Otc Drug
0555-9034Balziva Norethindrone And Ethinyl EstradiolKitTeva Pharmaceuticals Usa, Inc.Human Prescription Drug
0574-0611Podofilox PodofiloxSolutionTopicalPadagis Us LlcHuman Prescription Drug
0574-7090Hydrocortisone Acetate Hydrocortisone AcetateSuppositoryRectalPadagis Us LlcHuman Prescription Drug
0574-7093Hydrocortisone Acetate Hydrocortisone AcetateSuppositoryRectalPadagis Us LlcHuman Prescription Drug
0591-2927Levalbuterol Tartrate Hfa Inhalation Levalbuterol TartrateAerosol, MeteredOralActavis Pharma, Inc.Human Prescription Drug
0591-3659Desvenlafaxine DesvenlafaxineTablet, Extended ReleaseOralActavis Pharma, Inc.Human Prescription Drug
0591-3660Desvenlafaxine DesvenlafaxineTablet, Extended ReleaseOralActavis Pharma, Inc.Human Prescription Drug
0591-4060Desvenlafaxine DesvenlafaxineTablet, Extended ReleaseOralActavis Pharma, Inc.Human Prescription Drug
0597-0075Spiriva HandiHalerTiotropium BromideCapsuleOral; Respiratory (inhalation)Boehringer Ingelheim Pharmaceuticals, Inc.Human Prescription Drug
0597-0164Glyxambi Empagliflozin And LinagliptinTablet, Film CoatedOralBoehringer Ingelheim Pharmaceuticals, Inc.Human Prescription Drug
0597-0182Glyxambi Empagliflozin And LinagliptinTablet, Film CoatedOralBoehringer Ingelheim Pharmaceuticals, Inc.Human Prescription Drug
0597-0270Jentadueto Xr Linagliptin And Metformin HydrochlorideTablet, Film Coated, Extended ReleaseOralBoehringer Ingelheim Pharmaceuticals, Inc.Human Prescription Drug
0597-0275Jentadueto Xr Linagliptin And Metformin HydrochlorideTablet, Film Coated, Extended ReleaseOralBoehringer Ingelheim Pharmaceuticals, Inc.Human Prescription Drug
0597-0280Synjardy XREmpagliflozin, Metformin HydrochlorideTablet, Extended ReleaseOralBoehringer Ingelheim Pharmaceuticals, Inc.Human Prescription Drug
0597-0290Synjardy XREmpagliflozin, Metformin HydrochlorideTablet, Extended ReleaseOralBoehringer Ingelheim Pharmaceuticals, Inc.Human Prescription Drug
0597-0295Synjardy XREmpagliflozin, Metformin HydrochlorideTablet, Extended ReleaseOralBoehringer Ingelheim Pharmaceuticals, Inc.Human Prescription Drug
0597-0300Synjardy XREmpagliflozin, Metformin HydrochlorideTablet, Extended ReleaseOralBoehringer Ingelheim Pharmaceuticals, Inc.Human Prescription Drug
0781-3450Cefazolin CefazolinInjection, Powder, For SolutionIntramuscular; Intravenous; ParenteralSandoz IncHuman Prescription Drug
0781-3451Cefazolin CefazolinInjection, Powder, For SolutionIntramuscular; Intravenous; ParenteralSandoz IncHuman Prescription Drug
0832-0111Amantadine Hydrochloride Amantadine HydrochlorideTabletOralUpsher-smith Laboratories, LlcHuman Prescription Drug
0832-1510Haloperidol HaloperidolTabletOralUpsher-smith Laboratories, LlcHuman Prescription Drug
0832-1520Haloperidol HaloperidolTabletOralUpsher-smith Laboratories, LlcHuman Prescription Drug
0832-1530Haloperidol HaloperidolTabletOralUpsher-smith Laboratories, LlcHuman Prescription Drug
0832-1540Haloperidol HaloperidolTabletOralUpsher-smith Laboratories, LlcHuman Prescription Drug
0832-1550Haloperidol HaloperidolTabletOralUpsher-smith Laboratories, LlcHuman Prescription Drug
0832-1560Haloperidol HaloperidolTabletOralUpsher-smith Laboratories, LlcHuman Prescription Drug
0904-2035Banophen Diphenhydramine HclCapsuleOralMajor PharmaceuticalsHuman Otc Drug
0904-2056Diphenhydramine Hydrochloride Diphenhydramine HydrochlorideCapsuleOralMajor PharmaceuticalsHuman Otc Drug
0904-5306Diphenhydramine Hydrochloride Diphenhydramine HydrochlorideCapsuleOralMajor PharmaceuticalsHuman Otc Drug
0904-6868Trazodone Hydrochloride Trazodone HydrochlorideTabletOralMajor PharmaceuticalsHuman Prescription Drug
0904-6869Trazodone Hydrochloride Trazodone HydrochlorideTabletOralMajor PharmaceuticalsHuman Prescription Drug
0904-7212Trazodone Hydrochloride Trazodone HydrochlorideTabletOralMajor PharmaceuticalsHuman Prescription Drug
13517-110Phenobarbital PhenobarbitalTabletOralE5 Pharma, LlcHuman Prescription Drug
13517-111Phenobarbital PhenobarbitalTabletOralE5 Pharma, LlcHuman Prescription Drug
13517-112Phenobarbital PhenobarbitalTabletOralE5 Pharma, LlcHuman Prescription Drug
13517-113Phenobarbital PhenobarbitalTabletOralE5 Pharma, LlcHuman Prescription Drug
13668-202Darifenacin DarifenacinTablet, Extended ReleaseOralTorrent Pharmaceuticals LimitedHuman Prescription Drug
13668-203Darifenacin DarifenacinTablet, Extended ReleaseOralTorrent Pharmaceuticals LimitedHuman Prescription Drug
17772-101Trokendi Xr TopiramateCapsule, Extended ReleaseOralSupernus PharmaceuticalsHuman Prescription Drug
17772-102Trokendi Xr TopiramateCapsule, Extended ReleaseOralSupernus PharmaceuticalsHuman Prescription Drug
17772-103Trokendi Xr TopiramateCapsule, Extended ReleaseOralSupernus PharmaceuticalsHuman Prescription Drug
17772-104Trokendi Xr TopiramateCapsule, Extended ReleaseOralSupernus PharmaceuticalsHuman Prescription Drug
23155-191Bupropion Hydrochloride Bupropion HydrochlorideTabletOralHeritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.Human Prescription Drug
23155-192Bupropion Hydrochloride Bupropion HydrochlorideTabletOralHeritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.Human Prescription Drug
23155-287Acetazolamide AcetazolamideTabletOralHeritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.Human Prescription Drug
23155-288Acetazolamide AcetazolamideTabletOralHeritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.Human Prescription Drug
23155-531Calcium Acetate Calcium AcetateCapsuleOralHeritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.Human Prescription Drug
27241-118Fenofibrate FenofibrateCapsuleOralAjanta Pharma Usa Inc.Human Prescription Drug
27241-119Fenofibrate FenofibrateCapsuleOralAjanta Pharma Usa Inc.Human Prescription Drug
27241-120Fenofibrate FenofibrateCapsuleOralAjanta Pharma Usa Inc.Human Prescription Drug
33342-190Amlodipine And Olmesartan Medoxomil Amlodipine And Olmesartan MedoxomilTablet, Film CoatedOralMacleods Pharmaceuticals LimitedHuman Prescription Drug
33342-191Amlodipine And Olmesartan Medoxomil Amlodipine And Olmesartan MedoxomilTablet, Film CoatedOralMacleods Pharmaceuticals LimitedHuman Prescription Drug
33342-192Amlodipine And Olmesartan Medoxomil Amlodipine And Olmesartan MedoxomilTablet, Film CoatedOralMacleods Pharmaceuticals LimitedHuman Prescription Drug
33342-193Amlodipine And Olmesartan Medoxomil Amlodipine And Olmesartan MedoxomilTablet, Film CoatedOralMacleods Pharmaceuticals LimitedHuman Prescription Drug
42806-011Sulindac SulindacTabletOralEpic Pharma, LlcHuman Prescription Drug
42806-018Sulindac SulindacTabletOralEpic Pharma, LlcHuman Prescription Drug
43598-291Pregabalin PregabalinCapsuleOralDr.reddys Laboratories IncHuman Prescription Drug
43598-292Pregabalin PregabalinCapsuleOralDr.reddys Laboratories IncHuman Prescription Drug
43598-293Pregabalin PregabalinCapsuleOralDr.reddys Laboratories IncHuman Prescription Drug
43598-294Pregabalin PregabalinCapsuleOralDr.reddys Laboratories IncHuman Prescription Drug
43598-295Pregabalin PregabalinCapsuleOralDr.reddys Laboratories IncHuman Prescription Drug
43598-296Pregabalin PregabalinCapsuleOralDr.reddys Laboratories IncHuman Prescription Drug
43598-297Pregabalin PregabalinCapsuleOralDr.reddys Laboratories IncHuman Prescription Drug
43598-298Pregabalin PregabalinCapsuleOralDr.reddys Laboratories IncHuman Prescription Drug
45802-049Triamcinolone Acetonide Triamcinolone AcetonideOintmentTopicalPadagis Israel Pharmaceuticals LtdHuman Prescription Drug
45802-054Triamcinolone Acetonide Triamcinolone AcetonideOintmentTopicalPadagis Israel Pharmaceuticals LtdHuman Prescription Drug
45802-055Triamcinolone Acetonide Triamcinolone AcetonideOintmentTopicalPadagis Israel Pharmaceuticals LtdHuman Prescription Drug
45802-101Benzoyl Peroxide Benzoyl PeroxideGelTopicalPadagis Israel Pharmaceuticals LtdHuman Otc Drug
45802-318Benzoyl Peroxide Benzoyl PeroxideSuspensionTopicalPadagis Israel Pharmaceuticals LtdHuman Otc Drug
45802-868Polyethylene Glycol 3350 Polyethylene Glycol 3350Powder, For SolutionOralPadagis Israel Pharmaceuticals LtdHuman Otc Drug
47781-306Nitrofurantoin Macrocrystals Nitrofurantoin MacrocrystalsCapsuleOralAlvogen Inc.Human Prescription Drug
47781-307Nitrofurantoin Macrocrystals Nitrofurantoin MacrocrystalsCapsuleOralAlvogen Inc.Human Prescription Drug
47781-308Nitrofurantoin Macrocrystals Nitrofurantoin MacrocrystalsCapsuleOralAlvogen Inc.Human Prescription Drug
47781-384Oseltamivir Phosphate For Oral Suspension Oseltamivir PhosphatePowder, For SuspensionOralAlvogen Inc.Human Prescription Drug
49281-752Tubersol Tuberculin Purified Protein DerivativeInjection, SolutionIntradermalSanofi Pasteur Inc.Human Prescription Drug
49502-500Epipen EpinephrineInjectionIntramuscularMylan Specialty L.p.Human Prescription Drug
49502-501Epipen Jr EpinephrineInjectionIntramuscularMylan Specialty L.p.Human Prescription Drug
49702-231Triumeq Abacavir Sulfate, Dolutegravir Sodium, LamivudineTablet, Film CoatedOralViiv Healthcare CompanyHuman Prescription Drug
49702-258Triumeq Pd Abacavir Sulfate, Dolutegravir Sodium, LamivudineKitViiv Healthcare CompanyHuman Prescription Drug
49884-561Lamotrigine Extended Release Lamotrigine Extended ReleaseTabletOralPar Pharmaceutical, Inc.Human Prescription Drug
49884-562Lamotrigine Extended Release Lamotrigine Extended ReleaseTabletOralPar Pharmaceutical, Inc.Human Prescription Drug
49884-563Lamotrigine Extended Release Lamotrigine Extended ReleaseTabletOralPar Pharmaceutical, Inc.Human Prescription Drug
49884-564Lamotrigine Extended Release Lamotrigine Extended ReleaseTabletOralPar Pharmaceutical, Inc.Human Prescription Drug
49884-604Lamotrigine Extended Release Lamotrigine Extended ReleaseTabletOralPar Pharmaceutical, Inc.Human Prescription Drug
49884-605Lamotrigine Extended Release Lamotrigine Extended ReleaseTabletOralPar Pharmaceutical, Inc.Human Prescription Drug
50242-041Cathflo Activase AlteplaseInjection, Powder, Lyophilized, For SolutionIntravenousGenentech, Inc.Human Prescription Drug
50474-370Briviact BrivaracetamTablet, Film CoatedOralUcb, Inc.Human Prescription Drug
50474-470Briviact BrivaracetamTablet, Film CoatedOralUcb, Inc.Human Prescription Drug
50474-570Briviact BrivaracetamTablet, Film CoatedOralUcb, Inc.Human Prescription Drug
50474-670Briviact BrivaracetamTablet, Film CoatedOralUcb, Inc.Human Prescription Drug
50474-770Briviact BrivaracetamTablet, Film CoatedOralUcb, Inc.Human Prescription Drug
50474-870Briviact BrivaracetamSolutionOralUcb, Inc.Human Prescription Drug
50474-970Briviact BrivaracetamInjection, SuspensionIntravenousUcb, Inc.Human Prescription Drug
50484-010Collagenase Santyl Collagenase SantylOintmentTopicalSmith & Nephew, IncHuman Prescription Drug
50580-487Tylenol Regular StrengthAcetaminophenCapsule, Liquid FilledOralJohnson & Johnson Consumer Inc.Human Otc Drug
51672-2131Childrens Loratadine Sugar FreeLoratadineSolutionOralTaro Pharmaceuticals U.s.a., Inc.Human Otc Drug
51862-855Carbidopa And Levodopa Carbidopa And LevodopaTabletOralMayne Pharma Commercial LlcHuman Prescription Drug
51862-856Carbidopa And Levodopa Carbidopa And LevodopaTabletOralMayne Pharma Commercial LlcHuman Prescription Drug
51862-858Carbidopa And Levodopa Carbidopa And LevodopaTabletOralMayne Pharma Commercial LlcHuman Prescription Drug
58914-301Rectiv NitroglycerinOintmentRectalAllergan, Inc.Human Prescription Drug
59310-579Proair HFAAlbuterol SulfateAerosol, MeteredRespiratory (inhalation)Teva Respiratory, LlcHuman Prescription Drug
59385-021Belbuca Buprenorphine HydrochlorideFilm, SolubleBuccalBiodelivery Sciences International IncHuman Prescription Drug
59385-022Belbuca Buprenorphine HydrochlorideFilm, SolubleBuccalBiodelivery Sciences International IncHuman Prescription Drug
59385-023Belbuca Buprenorphine HydrochlorideFilm, SolubleBuccalBiodelivery Sciences International IncHuman Prescription Drug
59385-024Belbuca Buprenorphine HydrochlorideFilm, SolubleBuccalBiodelivery Sciences International IncHuman Prescription Drug
59385-025Belbuca Buprenorphine HydrochlorideFilm, SolubleBuccalBiodelivery Sciences International IncHuman Prescription Drug
59385-026Belbuca Buprenorphine HydrochlorideFilm, SolubleBuccalBiodelivery Sciences International IncHuman Prescription Drug
59385-027Belbuca Buprenorphine HydrochlorideFilm, SolubleBuccalBiodelivery Sciences International IncHuman Prescription Drug
59385-041Symproic NaldemedineTabletOralBiodelivery Sciences International IncHuman Prescription Drug
59651-032Ibuprofen Ibuprofen OralSuspensionOralAurobindo Pharma LimitedHuman Prescription Drug
59651-104Eletriptan Hydrobromide Eletriptan HydrobromideTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
59651-105Eletriptan Hydrobromide Eletriptan HydrobromideTablet, Film CoatedOralAurobindo Pharma LimitedHuman Prescription Drug
59762-4537Medroxyprogesterone Acetate Medroxyprogesterone AcetateInjection, SuspensionIntramuscularGreenstone LlcHuman Prescription Drug
59762-4538Medroxyprogesterone Acetate Medroxyprogesterone AcetateInjection, SuspensionIntramuscularGreenstone LlcHuman Prescription Drug
59922-631Auryxia Ferric CitrateTablet, Film CoatedOralAkebia Therapeutics, Inc.Human Prescription Drug
60505-0593Travoprost TravoprostSolutionOphthalmicApotex Corp.Human Prescription Drug
60505-0791Enoxaparin Sodium Enoxaparin SodiumInjectionSubcutaneousApotex Corp.Human Prescription Drug
60505-0792Enoxaparin Sodium Enoxaparin SodiumInjectionSubcutaneousApotex Corp.Human Prescription Drug
60505-0793Enoxaparin Sodium Enoxaparin SodiumInjectionSubcutaneousApotex Corp.Human Prescription Drug
60505-0794Enoxaparin Sodium Enoxaparin SodiumInjectionSubcutaneousApotex Corp.Human Prescription Drug
60505-0795Enoxaparin Sodium Enoxaparin SodiumInjectionSubcutaneousApotex Corp.Human Prescription Drug
60505-0796Enoxaparin Sodium Enoxaparin SodiumInjectionSubcutaneousApotex Corp.Human Prescription Drug
60505-0798Enoxaparin Sodium Enoxaparin SodiumInjectionSubcutaneousApotex Corp.Human Prescription Drug
60505-0813Butorphanol Tartrate Butorphanol TartrateSprayNasalApotex Corp.Human Prescription Drug
60505-1005Timolol Maleate Timolol MaleateSolution/ DropsOphthalmicApotex CorpHuman Prescription Drug
60631-040Edarbi Azilsartan KamedoxomilTabletOralAzurity Pharmaceuticals, Inc.Human Prescription Drug
60631-080Edarbi Azilsartan KamedoxomilTabletOralAzurity Pharmaceuticals, Inc.Human Prescription Drug
60631-412Edarbyclor Azilsartan Kamedoxomil And ChlorthalidoneTabletOralAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)Human Prescription Drug
60631-425Edarbyclor Azilsartan Kamedoxomil And ChlorthalidoneTabletOralAzurity Pharmaceuticals, Inc. (formerly Arbor Pharmaceuticals)Human Prescription Drug
60793-850Levoxyl Levothyroxine SodiumTabletOralPfizer Laboratories Div Pfizer IncHuman Prescription Drug
60793-851Levoxyl Levothyroxine SodiumTabletOralPfizer Laboratories Div Pfizer IncHuman Prescription Drug
60793-852Levoxyl Levothyroxine SodiumTabletOralPfizer Laboratories Div Pfizer IncHuman Prescription Drug
60793-853Levoxyl Levothyroxine SodiumTabletOralPfizer Laboratories Div Pfizer IncHuman Prescription Drug
60793-854Levoxyl Levothyroxine SodiumTabletOralPfizer Laboratories Div Pfizer IncHuman Prescription Drug
60793-855Levoxyl Levothyroxine SodiumTabletOralPfizer Laboratories Div Pfizer IncHuman Prescription Drug
60793-856Levoxyl Levothyroxine SodiumTabletOralPfizer Laboratories Div Pfizer IncHuman Prescription Drug
60793-857Levoxyl Levothyroxine SodiumTabletOralPfizer Laboratories Div Pfizer IncHuman Prescription Drug
60793-858Levoxyl Levothyroxine SodiumTabletOralPfizer Laboratories Div Pfizer IncHuman Prescription Drug
60793-859Levoxyl Levothyroxine SodiumTabletOralPfizer Laboratories Div Pfizer IncHuman Prescription Drug
60793-860Levoxyl Levothyroxine SodiumTabletOralPfizer Laboratories Div Pfizer IncHuman Prescription Drug
61703-350Methotrexate MethotrexateInjection, SolutionIntramuscular; Intravenous; SubcutaneousHospira, Inc.Human Prescription Drug
61703-350Methotrexate MethotrexateInjection, SolutionIntramuscular; Intravenous; SubcutaneousHospira, Inc.Human Prescription Drug
61703-408Methotrexate MethotrexateInjection, SolutionIntramuscular; Intrathecal; Intravenous; SubcutaneousHospira, Inc.Human Prescription Drug
61703-408Methotrexate MethotrexateInjection, SolutionIntramuscular; Intrathecal; Intravenous; SubcutaneousHospira, Inc.Human Prescription Drug
62175-617Pantoprazole Sodium Pantoprazole SodiumTablet, Delayed ReleaseOralLannett Company, Inc.Human Prescription Drug
62175-618Pantoprazole Sodium Pantoprazole SodiumTablet, Delayed ReleaseOralLannett Company, Inc.Human Prescription Drug
62332-115Metoprolol Tartrate And Hydrochlorothiazide Metoprolol Tartrate And HydrochlorothiazideTabletOralAlembic Pharmaceuticals Inc.Human Prescription Drug
62332-116Metoprolol Tartrate And Hydrochlorothiazide Metoprolol Tartrate And HydrochlorothiazideTabletOralAlembic Pharmaceuticals Inc.Human Prescription Drug
62332-117Metoprolol Tartrate And Hydrochlorothiazide Metoprolol Tartrate And HydrochlorothiazideTabletOralAlembic Pharmaceuticals Inc.Human Prescription Drug
62332-508Bromfenac Ophthalmic Solution 0.09% Bromfenac Ophthalmic Solution 0.09%Solution/ DropsOphthalmicAlembic Pharmaceuticals Inc.Human Prescription Drug
62856-582Banzel RufinamideTablet, Film CoatedOralEisai Inc.Human Prescription Drug
62856-583Banzel RufinamideTablet, Film CoatedOralEisai Inc.Human Prescription Drug
62856-584Banzel RufinamideSuspensionOralEisai Inc.Human Prescription Drug
63304-692Clindamycin Hydrochloride Clindamycin HydrochlorideCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
63304-693Clindamycin Hydrochloride Clindamycin HydrochlorideCapsuleOralSun Pharmaceutical Industries, Inc.Human Prescription Drug
64597-301Nuedexta Dextromethorphan Hydrobromide And Quinidine SulfateCapsule, Gelatin CoatedOralAvanir Pharmaceuticals, Inc.Human Prescription Drug
64661-650Enbrace Hr Levomefolate Magnesium, Leucovorin, Folic Acid, Ferrous Cysteine Glycinate, Magnesium Ascorbate, Zinc Ascorbate, Cocarboxylase, Flavin Adenine Dinucleotide, Nadh, Pyridoxal Phosphate Anhydrous, Cobamamide, Betaine, Magnesium L-threonate, 1,2-docosahexanoyl-sn-glycero-3-phosphoserine Calcium, 1,2-icosapentoyl-sn-glycero-3-phosphoserine Calcium, And Phosphatidyl SerineCapsule, Delayed Release PelletsOralJaymac PharmaHuman Prescription Drug
64764-119Colcrys ColchicineTablet, Film CoatedOralTakeda Pharmaceuticals America, Inc.Human Prescription Drug
66869-104Livalo Pitavastatin CalciumTablet, Film CoatedOralKowa Pharmaceuticals America, Inc.Human Prescription Drug
66869-204Livalo Pitavastatin CalciumTablet, Film CoatedOralKowa Pharmaceuticals America, Inc.Human Prescription Drug
66869-404Livalo Pitavastatin CalciumTablet, Film CoatedOralKowa Pharmaceuticals America, Inc.Human Prescription Drug
68047-186Nohist Dm Chlorpheniramine Maleate, Dextromethorphan Hydrobromide And Phenylephrine HydrochlorideLiquidOralLarken Laboratories, Inc.Human Otc Drug
68180-837Tri-lo-marzia Norgestimate And Ethinyl EstradiolKitLupin Pharmaceuticals, Inc.Human Prescription Drug
68462-260Verapamil Hydrochloride Verapamil HydrochlorideTablet, Film Coated, Extended ReleaseOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-292Verapamil Hydrochloride Verapamil HydrochlorideTablet, Film Coated, Extended ReleaseOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-293Verapamil Hydrochloride Verapamil HydrochlorideTablet, Film Coated, Extended ReleaseOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-321Ezetimibe And Simvastatin Ezetimibe And SimvastatinTabletOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-322Ezetimibe And Simvastatin Ezetimibe And SimvastatinTabletOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-323Ezetimibe And Simvastatin Ezetimibe And SimvastatinTabletOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-324Ezetimibe And Simvastatin Ezetimibe And SimvastatinTabletOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-356Theophylline TheophyllineTablet, Extended ReleaseOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
68462-380Theophylline TheophyllineTablet, Extended ReleaseOralGlenmark Pharmaceuticals Inc., UsaHuman Prescription Drug
69097-158Meloxicam MeloxicamTabletOralCipla Usa Inc.Human Prescription Drug
69097-159Meloxicam MeloxicamTabletOralCipla Usa Inc.Human Prescription Drug
69097-867Nadolol NadololTabletOralCipla Usa Inc.Human Prescription Drug
69097-868Nadolol NadololTabletOralCipla Usa Inc.Human Prescription Drug
69097-869Nadolol NadololTabletOralCipla Usa Inc.Human Prescription Drug
69238-1484Erythromycin ErythromycinTablet, Film CoatedOralAmneal Pharmaceuticals Ny LlcHuman Prescription Drug
69238-1485Erythromycin ErythromycinTablet, Film CoatedOralAmneal Pharmaceuticals Ny LlcHuman Prescription Drug
69547-212Narcan Naloxone HydrochlorideSprayNasalEmergent Devices Inc.Human Prescription Drug
69547-353Narcan Naloxone HydrochlorideSprayNasalEmergent Devices Inc.Human Prescription Drug
69680-112Cyanocobalamin CyanocobalaminInjection, SolutionIntramuscularVitruvias TherapeuticsHuman Prescription Drug
69680-113Cyanocobalamin CyanocobalaminInjection, SolutionIntramuscularVitruvias TherapeuticsHuman Prescription Drug
69680-121Cyanocobalamin CyanocobalaminInjection, SolutionIntramuscularVitruvias TherapeuticsHuman Prescription Drug
70515-610Prilosec Omeprazole MagnesiumGranule, Delayed ReleaseOralCovis Pharma Us, IncHuman Prescription Drug
70515-625Prilosec Omeprazole MagnesiumGranule, Delayed ReleaseOralCovis Pharma Us, IncHuman Prescription Drug
71858-0005Tirosint Levothyroxine SodiumCapsuleOralIbsa Pharma Inc.Human Prescription Drug
71858-0010Tirosint Levothyroxine SodiumCapsuleOralIbsa Pharma Inc.Human Prescription Drug
71858-0012Tirosint Levothyroxine SodiumCapsuleOralIbsa Pharma Inc.Human Prescription Drug
71858-0013Tirosint Levothyroxine SodiumCapsuleOralIbsa Pharma Inc.Human Prescription Drug
71858-0015Tirosint Levothyroxine SodiumCapsuleOralIbsa Pharma Inc.Human Prescription Drug
71858-0017Tirosint Levothyroxine SodiumCapsuleOralIbsa Pharma Inc.Human Prescription Drug
71858-0020Tirosint Levothyroxine SodiumCapsuleOralIbsa Pharma Inc.Human Prescription Drug
71858-0025Tirosint Levothyroxine SodiumCapsuleOralIbsa Pharma Inc.Human Prescription Drug
71858-0030Tirosint Levothyroxine SodiumCapsuleOralIbsa Pharma Inc.Human Prescription Drug
71858-0035Tirosint Levothyroxine SodiumCapsuleOralIbsa Pharma Inc.Human Prescription Drug
71858-0040Tirosint Levothyroxine SodiumCapsuleOralIbsa Pharma Inc.Human Prescription Drug
71858-0045Tirosint Levothyroxine SodiumCapsuleOralIbsa Pharma Inc.Human Prescription Drug
71858-0050Tirosint Levothyroxine SodiumCapsuleOralIbsa Pharma Inc.Human Prescription Drug
71858-0055Tirosint Levothyroxine SodiumCapsuleOralIbsa Pharma Inc.Human Prescription Drug
71858-0060Tirosint Levothyroxine SodiumCapsuleOralIbsa Pharma Inc.Human Prescription Drug
71930-026Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Brompheniramine Maleate, Pseudoephedrine Hydrochloride,SyrupOralEywa Pharma IncHuman Prescription Drug
72485-221Gemcitabine Gemcitabine HydrochlorideInjectionIntravenousArmas Pharmaceuticals Inc.Human Prescription Drug
72618-3000Nurtec Odt Rimegepant SulfateTablet, Orally DisintegratingOralPfizer Laboratories Div Pfizer IncHuman Prescription Drug
72618-3001Nurtec Odt Rimegepant SulfateTablet, Orally DisintegratingOralPfizer Laboratories Div Pfizer IncHuman Prescription Drug