🍔 Food 💊 Drugs 🏥 Medical Devices
Tikosyn¿ (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, NDC 00069-5820-60 Class II

Reason: Presence of Foriegn Tablets/Capsules: A single Tikosyn¿ (dofetilide) 250 mcg capsule was discovered in one bottle of Tikosyn¿ (dofetilide) 500 mcg (0.5 mg).

Pfizer Inc. 20140408 Terminated
Distributed: US Nationwide including Puerto Rico and US Virgin Islands. 65 federal government accounts received the affected product directly from Pfizer Inc
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Glycopyrrolate (MDV) 0.2 MG/ML Injectable, 5 mL Vials, Sterile Serum Vials/Sterile Syringes, for use by a licensed professional only, not for resale, MD Custom Rx, 19035 W Capitol Dr Ste 105, Brookfield, WI 53045. Class I

Reason: Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.

Brookfield Prescription Center Inc 20131113 Terminated
Distributed: WI
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VPRIV¿ (velaglucerase alfa for injection) , Lyophilized Powder, 400 Units/vial, Rx Only. Shire Human Genetic Therapies, Inc. 300 Shire Way, Lexington, MA 02421. NDC: 54092-701-04. Class I

Reason: Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.

Shire Human Genetic Therapies, Inc. 20140314 Terminated
Distributed: US Nationwide including Puerto Rico; Mexico, Columbia
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XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box Class I

Reason: Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.

Dolphin Intertrade Corporation 20130520 Terminated
Distributed: Nationwide
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JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle Class I

Reason: Marketed without an Approved NDA/ANDA: Products found to contain undeclared sibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs.

Dolphin Intertrade Corporation 20130520 Terminated
Distributed: Nationwide
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RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309 Class I

Reason: Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil.

Fossil Fuel Products, LLC 20131118 Terminated
Distributed: Nationwide.
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Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint Flavored Lozenges + 21 31 mg Patches. OTC Only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1480-30-2. Class III

Reason: Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline 20140220 Terminated
Distributed: U.S. Nationwide
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Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Lozenge and 81 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0509-04, 81 Count NDC: 0135-0509-02. Class III

Reason: Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline 20140220 Terminated
Distributed: U.S. Nationwide
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Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Lozenge, 27 Lozenge, 81 Lozenge and 135 Lozenge Vials, OTC. Distributed by GlaxoSmithKline Consumer Healthcare, LP, Moon Township, PA 15108, Made in Switzerland. 20 Count NDC: 0135-0508-04, 27 Count NDC: 0135-0508-03, 81 Count NDC: 0135-0508-02, 135 Count NDC: 0125-0508-03. Class III

Reason: Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline 20140220 Terminated
Distributed: U.S. Nationwide
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Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combination. Contains 30 Pieces/ Pallet. OTC only. GlaxoSmithKlein, 1000 GSK Drive, Moon Township, PA 15108. UPC: 0-03-0766-1442-81-2. Class III

Reason: Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.

GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline 20140220 Terminated
Distributed: U.S. Nationwide
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