Drug and pharmaceutical recalls
17747 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2014-04-30FDA-DrugHospira Inc.Class IIPotassium Chloride for Inj. Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Single-dose Fliptop Vial, For IV use, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA
Presence of Particulate; red and black particulate within the solution and embedded within the plastic vial identified as iron oxide
- 2014-04-30FDA-DrugOhm Laboratories, Inc.Class IINon-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongestant, Pseudoephedrine Sulfate, USP 240 mg , Loratadine, USP, 10 mg, 5, 10, 15 count blister packs, OTC Only. Labeled A) CVS Allergy Relief - D, Pseudoephedrine, USP 240 mg/Nasal Decongestant Loratadine, USP 10 mg/Antihistamine Extended Release Tablets, 5-count box Distributed by CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 02805 UPC 050428049631 B) Discount Drug Mart Non-Drowsy 24 Hour Formula Allergy Relief and Nasal Decongest
Defective Container: An unacceptable level of blister defects have been identified in Loratadine and Pseudoephedrine Sulfate Extended Release Tablets, 10 mg/240 mg.
- 2014-04-30FDA-DrugUpsher Smith Laboratories, Inc.Class IIIOxandrolone Tablets, USP, 10 mg, Rx Only, C-III, 60-count bottle, Manufactured for: Upsher-Smith Labs, Minneapolis, MN 55447, by: Pharmaceutics International, Inc., Hunt Valley, MD 21031, NDC 0245-0272-06
Labeling: Missing Label; Three cases of product (total of 36 bottles) were packaged without the primary label on the bottle. The cases were, however, packaged in the correct finished product shipper, labeled with the correct shipper bar code label, sealed with tamper-evident tape and erroneously shipped to Upsher-Smith.
- 2014-04-30FDA-DrugP&L Developments, LLCClass IIIDay Time Cold & Flu, Multi-Symptom, Non-Drowsy, Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl, 4, 6, 8, 10, and 12 oz Bottles, OTC Only. Labeled A) Aaron Health, 10 FL OZ, Manufactured by Aaron Industries, P.O. Box 801, Lynwood, CA 90262, UPC: 7 15256 73510 0; B) Aaron Health, 8 FL OZ, Manufactured by: PL Developments, 11865 S. Alameda St, Lynwood, CA 90262, UPC: 7 15256 71428 0; C) Aaron Brands, 6 FL OZ, Manufactured by: Aaron Industries, Inc., P.O. Box 801, Lynwood, CA 90262, UPC: 7
Subpotent Drug: Phenylephrine component is subpotent.
- 2014-04-30FDA-DrugPfizer Inc.Class IITikosyn¿ (dofetilide) 500 mcg (0.5mg) capsules, 60-count bottle, Rx only Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, NDC 00069-5820-60
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).
- 2014-04-30FDA-DrugBrookfield Prescription Center IncClass IGlycopyrrolate (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.
Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.
- 2014-04-30FDA-DrugShire Human Genetic Therapies, Inc.Class IVPRIV¿ (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.
Presence of Particulate Matter; Particulates identified as stainless steel and barium sulfate.
- 2014-04-30FDA-DrugDolphin Intertrade CorporationClass IXIYOUJI QINGZHI CAPSULE, 300mg, 20 count box
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.
- 2014-04-30FDA-DrugDolphin Intertrade CorporationClass IJaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle
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.
- 2014-04-30FDA-DrugFossil Fuel Products, LLCClass IRezzRX capsules, Single Blister Pack and 20 count bottle, Distributed By: Fossil Fuel Products, LLC Atlanta, GA 30309
Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil.
- 2014-04-30FDA-DrugGlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKlineClass IIINicorette 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.
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
- 2014-04-30FDA-DrugGlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKlineClass IIINicorette (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.
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
- 2014-04-30FDA-DrugGlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKlineClass IIINicorette (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.
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
- 2014-04-30FDA-DrugGlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKlineClass IIINicorette 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.
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
- 2014-04-30FDA-DrugGlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKlineClass IIINicotine 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.
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
- 2014-04-30FDA-DrugGlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKlineClass IIINicotine 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.
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
- 2014-04-30FDA-DrugGlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKlineClass IIINicotine 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.
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
- 2014-04-30FDA-DrugGlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKlineClass IIINicotine 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 R
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
- 2014-04-30FDA-DrugGlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKlineClass IIINicotine 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., 20
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
- 2014-04-30FDA-DrugGlaxoSmithKline Consumer Healthcare; dba-GlaxoSmithKlineClass IIINicotine 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 Wilm
Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent.
- 2014-04-23FDA-DrugHaute Health, LLCClass IVirilis 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
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.
- 2014-04-23FDA-DrugHaute Health, LLCClass IPHUK 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.
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.
- 2014-04-23FDA-DrugHaute Health, LLCClass IProlifta 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.
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.
- 2014-04-23FDA-DrugHospira, Inc.Class I1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., Lake Forest, IL 60045.
Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochloride Injection, USP.
- 2014-04-23FDA-DrugB @ B Trade Inc.Class ISlim Expert softgel capsules Dietary Supplement. One month supply/ 30 softgels. 1 softgel - 650 mg.
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
- 2014-04-23FDA-DrugB @ B Trade Inc.Class ILidiy capsules Dietary Supplement. Each bottle contains 30 capsules.
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
- 2014-04-23FDA-DrugB @ B Trade Inc.Class ISlim Fortune capsules Dietary Supplement. Each bottle contains 30 capsules.
Marketed Without an Approved NDA/ANDA; product found to contain undeclared sibutramine
- 2014-04-16FDA-DrugBoehringer Ingelheim Roxane IncClass IIISpiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spiriva Capsules, For Use With HandiHaler Only, 18 mcg (as tiotropium) per capsule, Rx Only, a) NDC 0597-0075-75, 5 Spiriva capsules per blister card, b) NDC 0597-0075-41, 30 Spiriva capsules per blister card, Manufactured by: Boehringer Ingelheim (BI) Pharma, GmbH & Co. KG, Ingelheim, Germany, Marketed by: Boehringer Ingelheim Pharmaceuticals Inc., Ridgefield, CT 06877 USA and Pfizer Inc New York, NY 10017 USA, Made in Ge
Defective Delivery System: Potential for dose delivery out of specification due to interation of the drug product powder with the lubricant on the interior of the capsule shell.
- 2014-04-16FDA-DrugGlenmark Generics Inc., USAClass IIRanitidine Tablets USP, 150 mg, 500-count bottles, Rx only, Manufactured by: Shasun Pharmaceuticals Limited, Unit-II R.S. No 32 33 & 34, Shasun Road, Periyakalapet, Puducherry, - 605 014, India; Manufactured for: Glenmark Generics Inc, USA, Mahwah, NJ 07430, UPC 3 68462 24805 8, NDC 68462-248-05.
Presence of Foreign Tablets/Capsules: Recall is due to a pharmacist complaint of a "foreign material", identified as Metoprolol Tartrate Tablet USP 50 mg, found co-mingled in a bottle of Ranitidine Tablets USP 150 mg.
- 2014-04-16FDA-DrugNovartis Pharmaceuticals Corp.Class IIIRitalin HCl (methylphenidate HCl) USP, 20 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp. Suffern, NY 10901 Dist. by: Novartis Pharmaceuticals Corp. East Hanover, New Jersey 07936, NDC 0078-0441-05
Labeling: Incorrect or Missing Package Insert; The back of the Medication Guide attached to the Package Insert for Ritalin Tablets was printed with information related to Ritalin SR (Sustained Release) Tablets. Both products, Ritalin Tablets and Ritalin SR Tablets utilize a combined Package Insert. The individual Medication Guides are attached to the Package Insert via a perforation. Although t
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