Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIVaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only Net wt. 1.59 oz (45 g) Rx only NDC 0023-4857-45 Manufactured for Allegan, Inc. Irvine, CA 92612
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIBROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIMetoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tablets Rx only NDC 62332-115-31 Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IICOSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hydrochloride 22.3 mg/mL Timolol Maleate 6.8 mg/mL) 10ML Ocumeter Plus Ophthalmic Dispenser Sterile Ophthlamic Solution Rx only NDC/UPC 174780-605-10 Distributed by: Akorn, Inc. Lake Forest, IL 60045
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIAtropine 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.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IILIDOCAINE HCL VISC 2% 100ML; NDC/UPC 50383077504; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIOFLOXACIN 0.3% 5ML OPTH; NDC/UPC 17478071310; RX; DROPS
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIFENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIMETHOCARBAMOL 500MG 500; NDC/UPC 71093014005; RX; TABLETS
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IISynthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and concentrations Rx only Abbott Laboratories North Chicago, IL
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IINorvir 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.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IIOrilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28 Tablets For 28 Days Rx only NDC 0074-0038-28 Each carton contains 28 tablets in 4 weekly blister pack, Each weekly blister pack contains 7 tablets of elagolix 150 mg AbbVie Inc. North Chicago, IL 60064
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IICreon (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.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IINIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugCardinal Health Inc.Class IITHERAPEUTIC M 130; NDC/UPC 740985223680; OTC; TABLETS
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
- 2021-06-02FDA-DrugAcella Pharmaceuticals, LLCClass INP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count bottles (NDC 42192-328-01) and b) 7-count bottles (NDC 42192-328-07) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
Subpotent Drug
- 2021-06-02FDA-DrugAcella Pharmaceuticals, LLCClass INP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-331-01
Subpotent Drug
- 2021-06-02FDA-DrugAcella Pharmaceuticals, LLCClass INP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-330-01
Subpotent Drug
- 2021-06-02FDA-DrugAcella Pharmaceuticals, LLCClass INP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count bottles (NDC 42192-329-01) and b) 7-count bottles (NDC 42192-329-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
Subpotent Drug
- 2021-06-02FDA-DrugAcella Pharmaceuticals, LLCClass INP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and b) 7-count bottles (NDC 42192-327-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
Subpotent Drug
- 2021-06-02FDA-DrugNoven Pharmaceuticals IncClass IIDaytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box (NDC 68968-5553-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
- 2021-06-02FDA-DrugNoven Pharmaceuticals IncClass IIDaytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) per box (NDC 68968-5552-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.
Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
- 2021-06-02FDA-DrugAscend Laboratories LLCClass IIIOlmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054, NDC 67877-446-30.
Presence of Foreign Tablet/Capsule
- 2021-05-26FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIICequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-506-96
Subpotent and Presence of Particulates .
- 2021-05-26FDA-DrugLupin Pharmaceuticals Inc.Class IICefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202 United States, Manufactured by: Lupin Limited, Manddeep, 462 046, India, NDC 68180-405-01
Subpotent Drug
- 2021-05-26FDA-DrugFresenius Medical Care, North AmericaClass IIDelflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius Medical Care North America, Waltham, MA 02451
Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
- 2021-05-26FDA-DrugBit & Bet LLCClass IIThumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673. Packaged in blister foil sheets in a box. Each box contains 10 capsules.
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
- 2021-05-26FDA-DrugNomax IncClass IIIDry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Pouches of 2 Strips Each), Manufactured by: Nomax, Inc, St. Louis, MO 63123, NDC: 51801-008-15
Subpotent Drug
- 2021-05-26FDA-DrugKVK-Tech, Inc.Class IIIHydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtown, PA, 18940 NDC 10702-055-03
Failed Impurities/Degradation Specifications
- 2021-05-26FDA-DrugPreferred Pharmaceuticals, Inc.Class IIPreferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 mg, Generic for Glucophage XR, Rx Only, Pkg Size: 100, Mfg: Time-Cap Labs Inc.; Farmingdale NY, NDC #: 68788-6932-1
CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.
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