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.
- 2012-10-03FDA-DrugHospira Inc.Class IIPropofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33; c) 100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA
Presence of Particulate Matter: A single visible particulate was observed and confirmed in sample bottles of the recalled lots during retain inspection.
- 2012-10-03FDA-DrugBracco Diagnostics IncClass IICARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Medi-Physics, Inc. South Plainfield, NJ 07080, NDC 0270-0091-01
GMP deviation; Sr-82 levels exceeded alert limit specification
- 2012-09-26FDA-DrugApace KY LLCClass IIIEnalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30
Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.
- 2012-09-26FDA-DrugHospira Inc.Class IIPaclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; N DC 61703-342-50
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
- 2012-09-26FDA-DrugHospira Inc.Class IIMethotrexate Injection, USP, 25 mg/mL, 40 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; NDC 61703-408-41
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
- 2012-09-26FDA-DrugHospira Inc.Class IICytarabine Injection, 20 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; NDC 61703-303-46
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
- 2012-09-26FDA-DrugHospira Inc.Class IICarboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-50 (Hospira label), NDC 61703-360-50 (Novoplus label)
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
- 2012-09-26FDA-DrugSandoz IncorporatedClass IIIPramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
- 2012-09-26FDA-DrugSandoz IncorporatedClass IIIPramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781- 5249-92,
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
- 2012-09-26FDA-DrugDukal Corp.Class IIDukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.133% w/v, Item 854-1000 contains 1000 individually packaged swabs per box. Item 854 contains 200 individually packaged swabs per box. Packaging labeled with Dukal Corporation, Hauppauge, NY 11788 --- NDC 65517-00031
Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)
- 2012-09-26FDA-DrugDukal Corp.Class IIZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), over the counter; supplied in 10 (item 2633), 50 (items 0204 and 02040 [sold in Canada only]) and 100 (item 0271) wipes per box distributed by ZEE MEDICAL, INC., Irvine, CA
Microbial contamination of Non Sterile Product; contamination with Burkholderia cepacia (manufacturer)
- 2012-09-26FDA-DrugCarefusion 213, LlcClass IIChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA
Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
- 2012-09-12FDA-DrugMedtech Products, Inc.Class IILittle Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL), Dist. by Medtech Products Inc., Irvington, NY 10533, UPC 7 56184 12071 2.
Subpotent (Single Ingredient) Drug: This product is being recalled because of sub-potency of the sennosides.
- 2012-09-05FDA-DrugHospira Inc.Class IIPropofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24
Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.
- 2012-09-05FDA-DrugNatural Essentials IncClass IIIOasis Age Essential (cetylpyridinium chloride) Mouthwash, 0.06%, 473 mL (16 fl oz) bottle, Oasis Consumer Healthcare LLC, 812 Huron Road, Cleveland, Ohio 44115, UPC 8 51076 00300 2.
Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.
- 2012-09-05FDA-DrugIsland Kinetics dba CovalenceClass IICosMedix Serious Protection, Natural SPF 28 Sunscreen, 3.3 fl.oz/100mL (100 g), Distributed by CosMedix, LLC, Atlanta, GA --- Also labeled as RESULTS RX, Serious Protection Rx, SPF 28 Sunscreen, Net Wt. 4oz/120g.
Microbial Contamination of Non Sterile Product; mold
- 2012-09-05FDA-DrugVistaPharm, Inc.Class IIIMETOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only, Manufactured by VistaPharm, Inc., Largo FL33771
Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," instead of "10 mL x 50,"
- 2012-09-05FDA-DrugAmerican Health PackagingClass IIMercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Packaged by American Health Packaging, 2550-A John Glenn Avenue, Columbus, OH 43217, barcode 6808432511; Carton labeling Dist by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977, NDC 68084-325-21.
Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.
- 2012-09-05FDA-DrugApotex Corp.Class IIIAzelastine HCl Nasal Solution, 0.1 %, 137 mcg/spray, 30 mL bottle (200 Metered Sprays), Rx only, Mfg by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, NDC 60505-0833-5.
CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.
- 2012-09-05FDA-DrugGlaxoSmithKline IncClass IIVentolin HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation, 200 Metered Inhalations, FOR ORAL INHALATION ONLY - For use with Ventolin HFA actuator only. Net. wt. 18 g Rx only, GlaxoSmithKline, Reasearch Triangle Park, NC 27709 NDC 0173-0682-20
Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.
- 2012-09-05FDA-DrugBracco Diagnostics IncClass IIMultihance Multipack (gadobenate dimeglumine) injection, 529 mg/mL, Pharmacy Bulk Package - Not for Direct Infusion, For Intravenous Use, Rx only, a) 50 mL Single Dose Vial, b) 100 mL Single Dose Vial, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Nycomed GmbH, 78224 Singen (Germany), NDC a) 0270-5264-16, b) 0270-5264-17.
Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.
- 2012-09-05FDA-DrugCapco Custom Packaging IncClass IIEco-Dent Sparkling Clean Mint Ultimate Essential MouthCare, Natural Daily Rinse and Oral Wound Cleanser/Oral Debriding Agent, 8 fl oz (237 mL) bottle, Alcohol Free, Dist By: Eco Dent, 1100 Lakes Dr., Silver Lake, WI 53170 USA, UPC Code: 00037541
Microbial Contamination of Non-Sterile Products; Product was found to be contaminated with Sphingomonas paucimobilis bacteria.
- 2012-09-05FDA-DrugBracco Diagnostics IncClass IIIBracco Diagnostics multihance (gadobenate dimeglumine) injection, 529 mg/mL, 20ml, Rx only, Manufactured for: Bracco Diagnostics Inc., Princeton, NJ 08543 USA, NDC 0270-5164-15
Short Fill: The product is being recalled due to a potential underfill of the affected vials.
- 2012-09-05FDA-DrugApotex Corp.Class IILeflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9, NDC 60505-2503-3
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
- 2012-09-05FDA-DrugApotex Corp.Class IILeflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
- 2012-09-05FDA-DrugGalderma Laboratories, L.P.Class IIICapex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galderma Laboratories, LP, Fort Worth, TX, Mfd. by: Hill Dermaceuticals, Inc., Sanford, FL --- NDC 0299-5500-04,
Subpotent; fluocinolone acetonide.
- 2012-08-29FDA-DrugPrometheus Laboratories Inc.Class IIMercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count tablets per bottle (NDC 49884-922-04), Rx only, Distributed by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
- 2012-08-29FDA-DrugVistaPharm, Inc.Class IIXactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume
- 2012-08-29FDA-DrugThe Menz Club, LLCClass IV Maxx Rx, All Natural Male Enhancement, a) 1-count blister pack UPC Code 2802803561; b) 5-count blister pack UPC Code 0972859402; c) 10-count bottle UPC code 0913251017 bottles, Manufactured by The Menz Club, LLC, 103 W. Washington Street, Suite B5, Ridgeland, MS 39157, Phone: 601-866-6746
Marketed Without An Approved NDA/ANDA: Samples tested by FDA were found to contain sulfoaildenafil, an analogue of sildenafil, an FDA approved drug used in the treatment of male erectile dysfunction, making these products unapproved new drugs.
- 2012-08-29FDA-DrugMorton Salt Co.Class IIIMorton, Sodium Chloride, USP, Granular, packaged in kraft paper bags, fiber drums, and semi-bulk bags. Product is shipped in 80 lb bags, 350 lb drums & 2000 lb semi-bulk sacks. Manufactured by Morton Salt, Inc., Chicago, Illinois 60606-1743.
Impurities/Degradation Products: The product was found to contain a slightly out of specification level of bromides, exceeding the bromides limit for USP Sodium Chloride.
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