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.
- 2012-07-18FDA-DrugKimberly-Clark CorporationClass IIKleenex Foam Hand Sanitizer, Alcohol Free in a) 1.5 fl oz. (45mL) , b) 8 fl oz. (236mL) , and c) 16 fl oz (473mL) bottles, Distributed by Kimberly Clark, LLC, Roswell, GA 30076
Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
- 2012-07-18FDA-DrugKimberly-Clark CorporationClass IIKleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Liter (33.8 fl oz.), b) 1.2 Liters (40.5 fl oz.) Cassettes, Distributed by Kimberly Clark, LLC, Roswell, GA 30076
Microbial Contamination of Non-Sterile Products; The affected lots were found to be contaminated with bacterium, Burkholderia cepacia complex.
- 2012-07-18FDA-DrugNoven Pharmaceuticals, Inc.Class IIDaytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12.
Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
- 2012-07-18FDA-DrugGlaxoSmithKline IncClass IITrizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 60 Tablets, Rx only, Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709 by: GlaxoSmithKline, Research Triangle Park, NC 27709, NDC 49702-217-18
Adulterated Presence of Foreign Tablets: Trizivir 300/150/300 mg tables, Lot 0ZP5128 may incorrectly contain Lexiva 700 mg tablets.
- 2012-07-18FDA-DrugVintage Pharmaceuticals LLC DBA Qualitest PharmaceuticalsClass IIIHYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.
Impurities/Degradation Products: Out of specificiation results for impurities at the 18-month room temperature time point.
- 2012-07-18FDA-DrugASTRA ZENECA LpClass IIINexium (esomeprazole magnesium) Delayed-Release Capsules, 40 mg, 1000-count bottle, Rx only, Manufactured for: AstraZeneca LP, Wilmington, DE 19850; By: AstraZeneca AB, S-151 85 Sodertalje, Sweden, NDC 0186-5040-85, UPC 3 0186-5040-85 0.
Adulterated Presence of Foreign Tablets/Capsules: Some bottles may contain a small number of Nexium 20 mg capsules intended for the Japanese market in addtion to Nexium 40 mg capsules.
- 2012-07-11FDA-DrugTeva Pharmaceuticals USA, Inc.Class IIMetoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactured in india By: Emcure Pharmaceuticals LTD. Hinjwadi, Pune, India, Manufactured for TEVA Phamaceuticals USA, Sellersville, PA 18960, NDC 0093-0733-10
Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight)
- 2012-07-11FDA-Drugsanofi-aventis US, Inc.Class IIEloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20
CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.
- 2012-07-11FDA-Drugsanofi-aventis US, Inc.Class IIEloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10
CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.
- 2012-07-11FDA-DrugHealth Plus IncorporatedClass IIISuper Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 doses, 100 capsules, Manufactured by: healthPLUS Inc. Chino, CA 91710 USA.
Labeling: Label Mix-up: The product is being recalled because active ingredient in the Drug Facts box incorrectly states "Active Ingredients per dose" Senna Leaf powder 140 mg. It should correctly be stated as "Active ingredient (in each capsule)" Senna Leaf Powder 140 mg.It should correctly be stated as Active ingredient (in each capsule) Senna Leaf Powder 140 mg.
- 2012-07-11FDA-DrugRanbaxy Inc.Class IIIBalnetar Therapeutic Tar Bath, Coal Tar USP 2.5% (from Coal Tar USP Solution, 7%), 7.5 oz bottle, Distributed by Ranbaxy, Jacksonville, FL 32257, NDC 10631-106-08
Subpotent (Single Ingredient Drug): out-of-specification result for coal tar content assay.
- 2012-07-11FDA-DrugMcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.Class IIIImodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg, 18 count blister pack cartons, McNeil Consumer Healthcare, Div of McNeil-PPC Inc., Fort Washington, PA
Defective Container; damaged blister units
- 2012-07-11FDA-DrugWatson Laboratories IncClass IIILoxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
- 2012-07-11FDA-DrugWatson Laboratories IncClass IIILoxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
- 2012-07-11FDA-DrugWatson Laboratories IncClass IIILoxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
- 2012-07-11FDA-DrugWatson Laboratories IncClass IIILoxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
- 2012-07-11FDA-DrugWatson Laboratories IncClass IIILoxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01.
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
- 2012-07-04FDA-DrugShionogi Inc.Class IINisoldipine Extended Release Tablets, 17mg, 100 count bottle, Rx only, Manufactured for: Prasco Laboratories Mason OH 45040, Manufactured by SkyePharma production SAS 38297, Saint Quentin-Pallavier, France, NDC: 0677-1979-01
Failed USP Dissolution Test Requirements: Out of Specification dissolution result at 18 month time point
- 2012-07-04FDA-DrugTeva Pharmaceuticals USA, Inc.Class IIZeosa (norethindrone and ethinyl estradiol tablets USP, (chewable), 0.4 mg/0.035 mg, and ferrous fumarate tablets USP, (chewable) 75 mg), 3 Blister Cards, 28 Tablets Each, Rx only, TEVA Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-2090-28 and 0093-2090-58, cartons containing three (3) individual blister packs
Impurities/Degradation: This recall is being carried out due to the potential for some lots not meeting impurity specifications.
- 2012-07-04FDA-DrugTeva Pharmaceuticals USA, Inc.Class IIMefloquine HCL Tablets, 250 mg, 5 tablets per blister pack; 5 Blister packs per carton, Rx only, Teva Pharmaceuticals USA Sellersville, PA 18960, Individual blister pack: NDC 0555-0171-88, 25 Unit-Dose Tablets (5x5) Carton: NDC 0555-0171-78
Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.
- 2012-07-04FDA-DrugLloyd IncClass IIThyro-Tab.075 mg., packaged in bulk drums for repackaging. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, Iowa 51601.
Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval.
- 2012-07-04FDA-DrugLloyd IncClass IILevothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, Iowa 51601
Subpotent (Single Ingredient Drug): Low assay at the 6-month test interval.
- 2012-07-04FDA-DrugLloyd IncClass IILevothroid (levothyroxine sodium tablets, USP), 50 mcg., packaged in 100-ct. bottles, RX, NDC 0456-1321-01. Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA.
Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.
- 2012-07-04FDA-DrugLloyd IncClass IIThyro-Tab 0.050mg., packaged in bulk drums for repackaging. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.
Subpotent (Single Ingredient Drug): Low assay at the 9-month test interval.
- 2012-07-04FDA-DrugPhysicians Total Care, Inc.Class IIMethylprednisolone Tablets, USP, 4 mg, 20 tablets per bottle, Repacked & Distributed by: Physicians Total Care Inc., Tulsa, OK 74146, NDC # 54868-2913-03
Impurities/Degradation Products; Product is being recalled due to the potential of not meeting the Impurity C specification through the product shelf life
- 2012-06-27FDA-DrugHospira, Inc.Class IIIMagnesium Sulfate in Water for Injection, 40 mg/mL (0.325 mEq Mg++/mL), 2 g total, 50 mL Flexible Container, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-6729-24.
Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.
- 2012-06-27FDA-DrugPhysicians Total Care, Inc.Class IILipitor (Atorvastatin calcium); 40 mg, 30 TABLETS, Rx only, Repacked & distributed: Physicians Total Care, Inc., Tulsa OK 74146, NDC 54868-4229-0
Chemical Contamination: Complaints of an uncharacteristic odor identified as 2,4,6 tribromoanisole.
- 2012-06-27FDA-DrugAbbott LaboratoriesClass IIZemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, 25 vial carton, Rx only, Manufactured by Hospira, Inc. For Abbott Laboratories, North Chicago, IL 60064, USA, NDC 0074-1658-05
CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection.
- 2012-06-27FDA-DrugKutol Products Co IncClass IIHands Down Medicated Lotion Soap, 1 gallon bottle, 4 gallons per case, Distributed by PCS Industries, Crestwood, IL, 60446
Labeling: Presence of Undeclared Additive: Medicated lotion soap produced and distributed by the recalling firm contains the unapproved ingredient, Red Dye #15. This dye is not approved for use in food, drugs or cosmetics.
- 2012-06-27FDA-DrugPhysicians Total Care, IncClass IMorphine Sulfate Immediate Release tablet, 30 mg/120 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, OK 74146-6234, NDC 54868-4973-00
Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.
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