FDA Recall
Terminated
Historical recordClass I
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.
by Shire Human Genetic Therapies, Inc.
- Reason
- Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
- Published
- April 30, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box
by Dolphin Intertrade Corporation
- 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.
- Published
- April 30, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle
by Dolphin Intertrade Corporation
- 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.
- Published
- April 30, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
RezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309
by Fossil Fuel Products, LLC
- Reason
- Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil.
- Published
- April 30, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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.
by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
- Reason
- Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
- Published
- April 30, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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.
by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
- Reason
- Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
- Published
- April 30, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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.
by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
- Reason
- Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
- Published
- April 30, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
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.
by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
- Reason
- Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
- Published
- April 30, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vials. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0511-05, 189 Count NDC: 0135-0511-03.
by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
- Reason
- Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
- Published
- April 30, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 count cartons. OTC. Labeled Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 81 Count NDC: 0135-0510-05, 189 Count NDC: 0135-0510-03.
by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
- Reason
- Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
- Published
- April 30, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0510-01,108 Count NDC: 0135-0514-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC: 30142-861-01. c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 108 Count NDC: 0363-0208-07.
by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
- Reason
- Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
- Published
- April 30, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0511-01,108 Count NDC: 0135-0515-03, b. Nicotine Lozenge Kroger, Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-862-01 and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0209-01, 108 Count NDC: 0363-0209-07.
by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
- Reason
- Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
- Published
- April 30, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count cartons, and 108 count cartons. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0513-01, 81 Count NDC: 0135-0513-02, 108 Count NDC: 0135-0513-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-664-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-9200-01.
by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
- Reason
- Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
- Published
- April 30, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vials, and 108 count vials. OTC. Labeled a. Nicorette, Distributed By: GlaxoSmithKline Consumer Healthcare, L.P., Moon Township, PA 15108. Made in Switzerland. 72 Count NDC: 0135-0512-01, 81 Count NDC: 0135-0512-02, 108 Count NDC: 0135-0512-03 b. Nicotine Lozenge Kroger, Distributed by: The Kroger Company, Cincinnati, Ohio 45202, 72 Count NDC:30142-663-01, and c. Nicotine Walgreens, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. 72 Count NDC: 0363-0446-01.
by GlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKline
- Reason
- Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
- Published
- April 30, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Virilis Pro, 450mg/capsule, Packaged in a 1 and 2 capsule blister packs and 10 capsule bottles, Manufactured for Haute Health Williamstown, NJ 08094 website: http://www.virilispro.com
by Haute Health, LLC
- Reason
- Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
- Published
- April 23, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
PHUK Sexual Enhancement Ultimate Pleasure, 400mg/capsule, packaged in 1 and 2 capsule blister packs and 4,12,24 capsule bottles, Distributed by UME Supplements, INC www.phukherbal.com.
by Haute Health, LLC
- Reason
- Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of active ingredients found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
- Published
- April 23, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Prolifta Dietary Supplement Prolifta, 400mg/capsule, Packaged in 1 and 2 capsule blister packs and 4, 12, and 24 capsule bottles Made in the USA Distributed by: Prolifta LLC 1+877.239.8231 www.proliftaherbal.com.
by Haute Health, LLC
- Reason
- Marketed without an Approved NDA/ANDA: Dietary supplement may contain amounts of an active ingredient found in some FDA-approved drugs for erectile dysfunction (ED) making the dietary supplement an unapproved drug.
- Published
- April 23, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., Lake Forest, IL 60045.
by Hospira, Inc.
- Reason
- Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.
- Published
- April 23, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Slim Expert softgel capsules Dietary Supplement. One month supply/ 30 softgels. 1 softgel - 650 mg.
by B @ B Trade Inc.
- Reason
- Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
- Published
- April 23, 2014
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Lidiy capsules Dietary Supplement. Each bottle contains 30 capsules.
by B @ B Trade Inc.
- Reason
- Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
- Published
- April 23, 2014
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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