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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 5221–5240 of 17,755 recalls

Class IITerminated

Estradiol Transdermal System, USP 0.1 mg/day (Twice-Weekly) Delivers 0.1 mg/day Rx only NDC 0378-4623-26 Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets. Rx only NDC 0006-0335-30 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08880, USA

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 capsules Rx only NDC 64597-301-60 Manufactured by Patheon, Inc. Whitby, ON L1N 5Z5, Canada

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

EPINEPHRINE INJECTION USP, 0.3MG (AUTO-INJECTORS) FOR ALLERGIC EMERGENCIES (ANAPHYLAXIS) 2 Auto-Injectors and 1 Trainer, Manufactured for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454 NDC 0093-5986-27

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Cetirizine Hydrochloride Tablets, 10 mg, 300 Count; NDC/UPC 345802919878; OTC; TABLETS

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

VIMPAT (lacosamide) Tablets, 200mg, 60-count bottle, Rx Only, Manufactured for: UCB, Inc. Smyrna, GA 30080, NDC 0131-2480-35

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Livalo (pitavastatin) tablets 2 mg* Rx Only NdC 66869-204-90 Manufactured under license from: Kowa Company, Limited Tokyo 103-8433 Japan Tablets Manufactured by: Patheon, Inc. Cincinnati, OH 45237 USA or by Kowa Company, Ltd Nagoya 462-0024 Japan

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Acne Medication Benzoyl Peroxide Gel USP, 5% Net Wt 1.5 oz (42.5 g) NDC 0536-1055-56 Distributed by: Rugby Laboratories 31778 Enterprise Drive, Livonia, MI 48150

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation With Dose Counter 200 Metered Inhalation 8,5 g Net Contents Rx only NDC 59310-579-22 Mktd by: Teva Respiratory, LLC Horsham, PA 19044 Mfd by: IVAX Pharmaceuticals Ireland Waterford, Ireland

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP,150MG 100-count bottles, Rx Only, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-692-01

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only NDC 62175-180-46 Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USA

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottle, Rx Only,/UPC 57664066683

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10 mg per capsule 30 capsules Rx Only NDC 0456-1214-30 Distributed by Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, LLC.

Cardinal Health Inc.

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

March 15, 2021 · DrugView details →

Class IITerminated

ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 10 mg vial, ZOMA-Jet 10 Demonstration Kit contains -ZOMA-Jet 10 device - 7 Needle-Free Head A's - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 19031 4.

Ferring Pharmaceuticals Inc

Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.

March 11, 2021 · DrugView details →

Class IITerminated

ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 Demonstration Kit contains -ZOMA-Jet 5 device - 5 Needle-Free Head A's - 2 Vial Adaptors - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 18031 5.

Ferring Pharmaceuticals Inc

Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.

March 11, 2021 · DrugView details →

Class IITerminated

Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10

Breckenridge Pharmaceutical, Inc

Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.

March 11, 2021 · DrugView details →

Class IITerminated

Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial packaged in 25 x 1 mL Single-Dose Vials per carton, For Intravenous Use, Rx only, Mfd. for: SAGENT Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC: 25021-315-01.

Sagent Pharmaceuticals Inc

Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.

March 11, 2021 · DrugView details →

Class ITerminated

Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, 160-count canister; Sanit Technologies, LLC, 7810 25th Court East, Sarasota, Florida 34243, UPC 8 52379 00631 8.

Sanit Technologies, LLC dba Durisan

Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.

March 10, 2021 · DrugView details →

Class ITerminated

heal the world, moisturizing original hand sanitizer, Non-Sterile Solution, Alcohol Antiseptic, 70% Topical Solution, 9.6 FL OZ. (285 mL) bottle, Heal The World, LLC, Draper, UT 84020, UPC 6 19988 44038 0.

PNHC, LLC.

Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.

March 10, 2021 · DrugView details →

Class IIOngoing

CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, packaged in a) 2 oz(56.8g) Tube, 76305-301-13 ; b) 4 oz (113.5 g) jar, UPC 6 87806 20004 1, NDC 76305-301-02 ; c) 6 OZ (170 g) tube, UPC 6 87806 20006 5, NDC 76305-301-03; d) 8 oz (226.8 g) Jar, UPC 6 87806 20008 9, NDC 76305-301-04; e) 16 oz ( 453.6 g) Bottle w/ Pump, UPC 6 87806 20016 4, NDC 76305-301-05; f) 120 oz (3.78L) gallon, UPC 6 87806 20128 4, NDC 76305-301-06: Distributed by: CHINA-GEL LLC, Arlington Heights, IL 60005,

China Gel Inc

CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.

March 10, 2021 · DrugView details →

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