McNeil Consumer Healthcare Recalls All Lots Of Rolaids Extra Strength Softchews, Roldaids Extra Strength Plus Gas Softchews, And Roldaids Multi-Symptom Plus Anti-Gas Softchews Sold In The U.S.
December 14, 2010
McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. is recalling all lots of ROLAIDS® Extra Strength Softchews, ROLAIDS® Extra Strength plus Gas Softchews, and ROLAIDS® Multi-Symptom plus Anti-Gas Softchews (full product details below) distributed in the United States.
Reese Pharmaceutical Recalls Over-The-Counter Cold Relief Products that are Mislabeled
December 11, 2010
Reese Pharmaceutical Company of Cleveland, OH has recalled lot# 091612 only in 60-count size bottles identified under four different brand names, listed in the table below, because cold decongestant tablets (containing Acetaminophen 325 mg, Phenylephrine 5 mg & Chlorpheniramine Maleate 2 mg) were mislabeled as containing only 200mg Guaifenesin tablets. This mislabeling could cause a consumer to ingest the product and unknowingly be exposed to serious side effects of acetaminophen, phenylephrine or chlorpheniramine.
Intelli Health Products Expands Recall of Duro Extend Capsules for Men Marketed as Dietary Supplements
December 7, 2010
Intelli Health Products announced today that it is expanding their voluntary nationwide recall of Duro Extend Capsules For Men, to include all lot codes. Intelli Health Products is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that laboratory analysis of Duro Extend Capsules For Men found the product to be adulterated with Sulfoaidenafil, an analogue of Sildenafil which is an FDA approved drug used in the treatment of Erectile Dysfunction (ED), making it an unapproved new drug.
Recall of Mylanta and Alternagel Liquid Products
November 29, 2010
RECALL OF MYLANTA AND ALTERNAGEL LIQUID PRODUCTS
 
CONTACT: CONSUMER CARE CENTER 1-800-469-5268
FOR IMMEDIATE RELEASE – NOVEMBER 29, 2010 – IN CONSULTATION WITH THE U.S. FOOD AND DRUG ADMINISTRATION (FDA), JOHNSON & JOHNSON-MERCK CONSUMER PHARMACEUTICALS, CO. (JJMCP) IS RECALLING, FROM THE WHOLESALE AND RETAIL LEVEL, TWELVE MYLANTA® LIQUID PRODUCTS AND ONE ALTERNAGEL® LIQUID PRODUCT. JJMCP IS CONDUCTING THE RECALL IN ORDER TO UPDATE THE LABELING FOR THESE PRODUCTS. THE SPECIFIC PRODUCTS INVOLVED, LISTED BELOW, ARE BEING RECALLED IN THE UNITED STATES AND PUERTO RICO.
Three Tylenol Cold Multi-Symptom Liquid Products Recalled
November 28, 2010
In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling, from the wholesale and retail level, three TYLENOL® Cold Multi-Symptom liquid products in order to update the labeling for these products. The specific products involved, listed below, are sold in the United States.
ROLAIDS® Extra Strength Softchews Recall
November 28, 2010
In consultation with the U.S. Food and Drug Administration (FDA), McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc. has initiated a voluntary recall of one product lot of ROLAIDS® Extra Strength Softchews, Cherry Flavor, 36 count package distributed in the United States.
Advanced Bionics Cochlear Implant Recall – Recalled HiRes 90K Hearing Aid Device
November 25, 2010
Advanced Bionics (AB) is recalling their HiRes 90K cochlear implant device and is retrieving all unimplanted devices in distribution. This implanted hearing aid recall is in response to two confirmed instances where the product experienced a malfunction requiring explantation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations after 8-10 days beyond initial activation of their HiRes 90k cochlear implant device.
WalkMed Infusion Issues Nationwide Recall of Triton Pole Mount Infusion Pumps
November 25, 2010
This is an update to a previously announced recall. WalkMed Infusion LLC, Englewood, Colorado, is conducting a nationwide recall of Triton Pole Mount Infusion Pumps. The reason for this recall is that the pump door open alarm does not always work on all pumps to alert the user that the pump door is open. In this state, the pump can still run even though the pump door may be open and could result in a free flow perfusion, and may cause serious injury or death.
Carefusion Recall of Alaris PC Units Model 8015 Classified as Class I Recall
November 6, 2010
WalkMed Infusion LLC, Englewood, Colorado, is initiating a nationwide recall of a total of 2018 Triton Pole Mount Infusion Pumps. The pumps have been found to possibly have a problem with the pump door open alarm, which potentially could result in over infusion of medication.
WalkMed Infusion Issues Nationwide Recall of Triton Infusion Pump
November 6, 2010
WalkMed Infusion LLC, Englewood, Colorado, is initiating a nationwide recall of a total of 2018 Triton Pole Mount Infusion Pumps. The pumps have been found to possibly have a problem with the pump door open alarm, which potentially could result in over infusion of medication.
Intelli Health Products Recalls Duro Extend Capsules for Men Marketed as Dietary Supplements
November 4, 2010
Intelli Health Products, announced today that it is conducting a voluntary nationwide recall of Duro Extend Capsules For Men. Intelli Health Products, is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that laboratory analysis of Duro Extend Capsules For Men sample found the product to be adulterated with Sulfoaidenafil, an analogue of sildenafil which is an FDA approved drug used in the treatment of Erectile Dysfunction(ED), making it an unapproved new drug.
Octopus Nuvo Tissue Stabilizer: Class I Recall
November 2, 2010
Medtronic, Inc. (NYSE: MDT) today announced the U.S. Food and Drug Administration (FDA) has classified the company’s previous action related to the Octopus® Nuvo Tissue Stabilizer as a Class I recall. FDA classifies a recall as Class I when the agency believes that there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death. On Sept. 14, 2010, Medtronic proactively and voluntarily recalled the device from the market due to the potential that a component of the device could fracture during use. The resulting potential hazards are that fragments of the component could fall into the patient’s chest cavity and/or damage the heart tissue. Medtronic has received two reports of device failure occurring during patient use, which required retrieval of device fragments from the surgical wound; neither event resulted in permanent impairment or death.
B. Braun Recalls Heparin: Contaminant
October 30, 2010
B. Braun Medical Inc. (B. Braun) was recently notified by its supplier, Scientific Protein Laboratories LLC (SPL), of a nationwide recall of a lot of Heparin Sodium USP Active Pharmaceutical Ingredient (API) sold to B. Braun because additional testing of retained crude heparin samples used by SPL to manufacture this single API lot indicated a trace amount of oversulfated chondroitin sulfate (OSCS) contaminant. As a result, B. Braun is initiating a voluntary recall of seven lots of heparin injection products to the healthcare provider level. These lots were manufactured in 2008 and will be expiring on October 31, 2010 and November 30, 2010.
Sandoz initiates voluntary recall in the US of all 50mg/2mL and 250mg/10mL vials of Methotrexate Injection, USP due to the presence of glass particulates
October 29, 2010
Sandoz Inc. announced today it has initiated a voluntary recall in the US of all 50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand Methotrexate Injection, USP product (“methotrexate”) to the consumer/user level. Consistent with its commitment to quality and patient safety, Sandoz is initiating this voluntary recall of all 24 lots of the affected product following the finding of small glass flakes by Sandoz quality control in a limited number of vials in four lots. The flakes are the result of delamination of the glass used to manufacture the vials of these two dosage presentations.
bioMerieux, Inc. Issues Urgent Product Correction for VITEK 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam
October 28, 2010
bioMerieux, Inc. on September 16, 2010, initiated a worldwide voluntary product correction of VITEK ® 2 Gram Negative Susceptibility Cards containing the antibiotic Piperacillin/Tazobactam (TZPv). These cards, manufactured after March 10, 2009, are used in clinical laboratories to perform antimicrobial susceptibility testing as part of the VITEK® System. Clinical laboratories were notified to perform an alternative method of testing prior to reporting results for:
Standard Homeopathic Company Recalls Hyland’s Teething Tablets to Address Manufacturing Process
October 25, 2010
Standard Homeopathic Company, in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling its Hyland’s Teething Tablets. The company is initiating this recall in an abundance of caution due to an FDA investigation of its manufacturing facility. Hyland’s Teething Tablets are manufactured in the United States and distributed throughout North America.
Actavis Inc. Issues a Voluntary Recall of 18 Lots of Fentanyl Transdermal System 25 mcg/h
October 22, 2010
Actavis Inc. announced a voluntary recall to the wholesale and retail levels only of 18 lots of Fentanyl Transdermal System 25 mcg/hour C-II patches manufactured for Actavis by Corium International in the United States.
McNeil Consumer Healthcare Recalls TYLENOL® 8 Hour Caplets
October 20, 2010
McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., is recalling one product lot of TYLENOL® 8 Hour caplets 50 count bottles to the retail level. McNeil is taking this action following a small number of complaints of a musty or moldy odor. The uncharacteristic odor is thought to be caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole. This voluntary action is being taken as a precaution and the risk of adverse medical events is remote. To date, observed events reported to McNeil for this lot were temporary and non-serious.
Excelsior Medical Recall of 5 ml Fill in 6 cc Prefilled Saline Flush Syringes
October 16, 2010
Excelsior Medical Corporation issued the following update regarding their previously disclosed nationwide recall of Excelsior Disposable 5ml fill in 6 cc Prefilled Saline Flush Syringe W/Normal Saline (0.9 % Sodium Chloride). The FDA has classified this action as a Class I recall. A Class I recall is a situation in which there is a reasonable probability that the use or exposure to a violative product will cause serious adverse health consequences or death.
40mg Lipitor Recall by Pfizer
October 10, 2010
Public Notice:
Pfizer recalled specific bottles of LIPITOR (40 mg only) due to a small number of reports of an uncharacteristic odor related to the bottles in which LIPITOR is packaged. A medical assessment has determined that the odor is not likely to cause adverse health consequences in patients taking LIPITOR. There is no need to take any action if you take LIPITOR; please continue to take your medication as prescribed by your doctor. However, if you take LIPITOR 40 mg and experience an uncharacteristic odor associated with your medication, please return the tablets to your pharmacist.
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