June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-1203-30 Distributed by: Allergan USA, Inc. Ir
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls 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
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls UBRELVY 100MG 10UD CPLT; NDC/UPC 23650110; RX; TABLETS
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Vaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only Net wt. 1.59 oz (45 g) Rx only NDC 0023-4857-45 Ma
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tablets Rx only NDC 62332-115-31 Manufactured f
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hydrochloride 22.3 mg/mL Timolol Mal
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Atropine Sulfate Ophthalmic Solution, USP 1% For Topical Application To The Eye Sterile 5 mL Rx only NDC 17478-215-05 Ma
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls LIDOCAINE HCL VISC 2% 100ML; NDC/UPC 50383077504; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS)
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls OFLOXACIN 0.3% 5ML OPTH; NDC/UPC 17478071310; RX; DROPS
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls METHOCARBAMOL 500MG 500; NDC/UPC 71093014005; RX; TABLETS
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and concentrations Rx only Abbott Laboratories N
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC 0074-3333-30 Abbott Laboratories North Chicago, IL 60064, U.S.A.
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28 Tablets For 28 Days Rx only NDC 0
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Units Rx only NDC 0032-3016-13 100
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls NIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Cardinal Health Inc. recalls THERAPEUTIC M 130; NDC/UPC 740985223680; OTC; TABLETS
Hazard: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
June 2, 2021DrugsFDA
Acella Pharmaceuticals, LLC recalls NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count bottles (NDC 42192-328-01) and b) 7-count
Hazard: Subpotent Drug
June 2, 2021DrugsFDA
Acella Pharmaceuticals, LLC recalls NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx only, Manufactured For: Acella Pharmaceutic
Hazard: Subpotent Drug
June 2, 2021DrugsFDA
Acella Pharmaceuticals, LLC recalls NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Manufactured For: Acella Pharmaceuticals,
Hazard: Subpotent Drug
June 2, 2021DrugsFDA
Acella Pharmaceuticals, LLC recalls NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count bottles (NDC 42192-329-01) and b) 7-count
Hazard: Subpotent Drug
June 2, 2021DrugsFDA
Acella Pharmaceuticals, LLC recalls NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and b) 7-count
Hazard: Subpotent Drug
June 2, 2021DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) pe
Hazard: Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
June 2, 2021DrugsFDA
Noven Pharmaceuticals Inc recalls Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) pe
Hazard: Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
June 2, 2021DrugsFDA
Ascend Laboratories LLC recalls Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013.
Hazard: Presence of Foreign Tablet/Capsule
May 26, 2021DrugsFDA
SUN PHARMACEUTICAL INDUSTRIES INC recalls Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx
Hazard: Subpotent and Presence of Particulates .
May 26, 2021DrugsFDA
Lupin Pharmaceuticals Inc. recalls Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Ba
Hazard: Subpotent Drug
May 26, 2021DrugsFDA
Fresenius Medical Care, North America recalls Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only,
Hazard: Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
May 26, 2021DrugsFDA
Bit & Bet LLC recalls Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673. Packaged in blister foil
Hazard: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.