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Nephron Pharmaceuticals recalls Albuterol Sulfate Inhalation Solution
Pfizer recalls 1 million packets of birth control
A packaging error has lead to the recall of 1 million packets of birth control that could lead to inadequate dosage and an accidental pregnancy. This error affects Lo/Ovral-28 tablets, generic Norgestrel and Ethinyl Estradiol tablets.
Pfizer found some of the packets had too many active tablets while some had too few. A Pfizer statement says this is not a safety issue however there is an increased risk of unintended pregnancy.
FDA issues recall on propoxyphene, brands Darvocet/Darvon
Xanodyne Pharmaceuticals Inc. which makes Darvon and Darvocet, the brand version of the prescription pain medication propoxyphene, has agreed to withdraw the medication from the U.S. market at the request of the U.S. Food and Drug Administration. The FDA has also informed the generic manufacturers of propoxyphene-containing products of Xanodyne’s decision and requested that they voluntarily remove their products as well.
The FDA sought market withdrawal of propoxyphene after receiving new clinical data showing that the drug puts patients at risk of potentially serious or even fatal heart rhythm abnormalities. As a result of these data, combined with other information, including new epidemiological data, the agency concluded that the risks of the medication outweigh the benefits.
The FDA is advising health care professionals to stop prescribing propoxyphene to their patients, and patients who are currently taking the drug should contact their health care professional as soon as possible to discuss switching to another pain management therapy.
The FDA now has reviewed the data from that study, which show that, even when taken at recommended doses, propoxyphene causes significant changes to the electrical activity of the heart. These changes, which can be seen on an electrocardiogram (ECG), can increase the risk for serious abnormal heart rhythms that have been linked to serious adverse effects, including sudden death. The available data also indicate that the risk of adverse events for any particular patient (even patients who have taken the drug for many years) is subject to change based on small changes in the health status of the patient, such as dehydration, a change in medications, or decreased kidney function.
Meridia recall issued by FDA, recommends patients stop taking and contact doctor immediately
Infant and Children's Tylenol, Motrin, Zyrtec, and Benadryl products Recalled
McNeil Consumer Healthcare and FDA notified healthcare professionals of a voluntary recall of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States, including Tylenol, Motrin, Zyrtec, and Benadryl products.
Parents and caregivers should not administer these products to their children.
Tylenol, Motrin, Rolaids Recalled
Johnson & Johnson continues their recall of Tylenol products and adds Motrin, Rolaids, some Benadryl products as well as St. Joseph's aspirin to the growing list. These products have an unusual musty, moldy, mildew type odor and will cause nausea, stomach pains, diarrhea and vomiting if consumed. Do NOT use these products if you believe an odor or strange smell is present.
ETHEX Corporation Initiated Nationwide Voluntary Recall of a Single Lot of Hydromorphone HCl 2 mg Tablets Due to Potential for Oversized Tablet
December 23, 2008 – ETHEX Corporation announced today that it has voluntarily recalled to the consumer level, a single production lot of Hydromorphone HCl 2 mg tablets (Lot #90219, Exp: 03/2010; NDC #58177-0620-04), as a precaution, due to the possibility it may contain oversized tablets. Hydromorphone is a drug used for pain management and is packaged under the ETHEX label in 100-count bottles.
If someone were to take a higher than expected dose of Hydromorphone, the risk of adverse effects known to be associated with the drug may be increased, including respiratory depression (difficulty or lack of breathing), low blood pressure, and sedation.
Johnson and Johnson--Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall Of Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) Non-Staining Due To Possible Metal Fragments
November 7, 2008 – Johnson & Johnson • Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON® GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA).
Consumers who purchased Infants' MYLICON® GAS RELIEF DYE FREE drops non-staining included in this recall should immediately stop using the product.
ETHEX Corporation Initiated Nationwide Voluntary Recalls of Specific Lots of Five Generic Products Due to the Potential for Oversized Tablets
November 7, 2008 – ETHEX Corporation announced today that it has voluntarily recalled to the consumer level specific lots of five generic /non-branded products that it markets. These lots have been recalled as a precaution, due to the possibility that they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage of these drugs.
Propafenone HCl Tablets - 150 mg, 225 mg, and 300 mg
Overdoses of Propafenone HCl, Isosorbide Mononitrate, Morphine sulfate and Dextroamphetamine Sulfate can have serious or life-threatening consequences. In the case of Propafenone HCl, these consequences can include arrhythmias (irregular heartbeat) and low blood pressure. In the case of Isosorbide Mononitrate, these consequences can include fainting and low blood pressure. In the case of Morphine Sulfate, these consequences can include respiratory depression (difficulty or lack of breathing) and low blood pressure. In the case of Dextroamphetamine Sulfate, these consequences can include rapid heart rate and high blood pressure.
International Pharmaceuticals, Ltd. Issues a Voluntary Recall of all Viril-Ity-Power (VIP) Tabs, a Product Marketed as a Dietary Supplement
May 29, 2008 - International Pharmaceuticals, Ltd. announced today that it is conducting a voluntary recall of all the company’s supplement product sold under the brand name of Viril-Ity-Power (VIP) Tabs, 560mg/serving.
International Pharmaceuticals, Ltd. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, hydroxyhomosildenafil. FDA asserts that this ingredient is an analog of sildenafil. Sildenafil is the active chemical ingredient of an FDA-approved drug used for Erectile Dysfunction (ED) in men to enhance sexual performance. The use of undeclared chemicals pose a threat to consumers because they may harmfully interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take such nitrates.
Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.
Medicis Announces Voluntary Recall of Solodyn® (minocycline HCL, USP) 90 Mg Tablets, Extended Release
May 16, 2008 -- Medicis today announced that the Company is voluntarily recalling lot numbers B080037 (Exp: 12/09) and B080038 (Exp: 12/09) of the antibiotic SOLODYN® (minocycline HCl, USP) Extended Release Tablets, 90 mg, 30-count bottles (NDC 99207-461-30). Medicis has received a report that one bottle in lot number B080037 contains AZASAN® (azathioprine tablets) 75 mg (NDC 65649-231-51) instead of SOLODYN® (minocycline HCl, USP) Extended Release Tablets, 90 mg. AZASAN® is an immuno-suppressive agent used in transplant patients to prevent kidney rejection and for the treatment of rheumatoid arthritis. Taking AZASAN® instead of SOLODYN® presents a health hazard and safety risk to patients. Side effects associated with the use of AZASAN®, particularly in the elderly, include mylosuppression (decrease in the number of red and white blood cells and platelets), infection, bleeding, chills, nausea, vomiting and diarrhea. Joint and muscle pain are also common side effects. Unanticipated interactions with other drugs may also lead to serious adverse events. SOLODYN® is manufactured by AAIPharma, Inc. under contract to Medicis. The two lots were manufactured during February 2008. The recall is limited to these lots, and ample supplies of SOLODYN® remain on the market.
Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek® (digoxin tablets, USP)
April 25, 2008 -- Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class I nationwide recall of Digitek® (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label.
Digitek® is used to treat heart failure and abnormal heart rhythms. The existence of double strength tablets poses a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake. Several reports of illnesses and injuries have been received.
Herbal Science International, Inc. Recalls Twelve Dietary Herbal Supplements Nationwide Because of Possible Health Risk Associated with Ephedra, Aristolochic Acid and Human Placenta
April 10, 2007- Herbal Science International, Inc. (AKA Jen-On Herbal Science International, Inc.) is recalling twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers.
FDA has long regarded dietary supplements containing ephedra as potential health hazards because this botanical contains ephedrine alkaloids. Ephedrine alkaloids are adrenaline-like stimulants that can have potentially dangerous effects on the heart. Recent studies have confirmed that ephedrine alkaloids raise blood pressure and otherwise stress the circulatory system, effects that are linked to adverse health effects like heart attacks and strokes. Based on this and other evidence in the scientific literature, FDA issued a rule in February 2004 prohibiting the sale of dietary supplements containing ephedrine alkaloids because they present an unreasonable risk of illness or injury.
Herbal Science International, Inc. is also recalling Tou Tong
San (Headache Formula) and Du Huo Ji Sheng Tang (Du Huo
Joint Relief), two products containing aristolochic acid.
Aristolochic acid is a potent carcinogen and nephrotoxin found in
certain plants and botanicals. This chemical can cause serious kidney
damage and the use of products that contain aristolochic acid has been
associated with several occurrences of kidney failure. These products
have also been linked to an increased risk of kidney cancer in people
who have consumed them.
All of the twelve products under voluntary recall are packed in white plastic bottles of 100 capsules. All lots are covered in this recall action. These products have been sold nationwide in herbal stores, by acupuncturists and on the internet.
Consumers who have purchased these products should immediately discontinue their use.
Actavis Recalls Remaining Fentanyl Patches in the US
March 1, 2008 -- Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group hf, today announced that its subsidiary Actavis South Atlantic LLC is proceeding with the voluntarily recall from wholesalers and pharmacies of all lots of Fentanyl transdermal system CII patches sold in the United States.
As per the approved product labelling for Fentanyl transdermal system, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are leaking or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches that may be damaged or compromised in any way by flushing them down the toilet, using caution not to handle them directly. Damaged and/or compromised patches that have leaked gel will not provide effective pain relief.
Palo Alto Labs Issues a Voluntary Nationwide Recall of Aspire36 and Aspire Lite, two Products Marketed as Dietary Supplements
February 28, 2008- Palo Alto Labs, 265 SW Port St. Lucie Blvd., Suite 252, Port St. Lucie, FL 34984, announced today that it is conducting a voluntary nationwide recall of the company's supplement products sold under the name Aspire36 and Aspire Lite. Palo Alto Labs is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Aspire36 and Aspire Lite samples found that the products contained Aildenafil in trace amounts and Dimethyl sildenafil thione (sulfoaildenafil) a purported analog of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). Sulfoaildenafil is close in structure to Sildenafil and is expected to possess a similar pharmacological and adverse event profile. This may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
Consumers who have Aspire36 and Aspire Lite in their possession should stop using them immediately.
February 28, 2008 – Baxter eding with the voluntary recall of all remaining lots anroceeding with the voluntary recall of all remaining lots and doses of its heparin sodiusis by FDA of Aspire36 and Aspire Lite samples found that thm injection multi-dose, single-dose vials and HEP-LOCK heparin flush products.
Given the widespread use of this blood thinner and the impact a product shortage would have on operating rooms, dialysis centers and other critical care areas, the FDA and Baxter concluded that removing additional lots and doses of Baxter's heparin from the market earlier would have created more risk to patients requiring heparin therapy than the increased potential for experiencing an adverse reaction. Accordingly, the FDA and Baxter decided not to recall all Baxter heparin vial products at that time. The FDA has now concluded that there is sufficient capacity on the part of other suppliers that Baxter's recall will not jeopardize access to this drug, and has told Baxter that the company can now proceed with recalling its remaining heparin sodium injection and heparin flush products.
Although the vast majority of the reports of adverse reactions have been associated with the multi-dose products, Baxter is taking the precautionary step of recalling all remaining heparin sodium injection and heparin flush products that are currently on the market. In addition to the previously recalled lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials, Baxter's recall will now include the remaining lots of those products and heparin sodium injection 5000 units/mL 10mL multi-dose vials, heparin sodium injection 10,000 units/mL 4mL multi-dose vials, heparin sodium injection 1000 USP units/mL, 5000 USP units/mL, and 10,000 USP units/mL single-dose vials, and all HEP-LOCK and HEP-LOCK U/P, 10 USP units/mL and 100 USP units/mL vials, both preserved and preservative-free.
Nearly all reported adverse reactions have occurred in three specific areas of product use – renal dialysis, invasive cardiovascular procedures and apheresis procedures. Reported adverse patient reactions have included: stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizziness, fainting, unresponsiveness, shortness of breath, the feeling of a strong or rapid heartbeat, drug ineffectiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, feeling unwell, restlessness, watery eyes, throat swelling, thirst, bleeding tendencies and difficulty opening the mouth. Some of these reactions, particularly profound and refractory hypotension, may be severe or life-threatening.
Actavis Recalls Certain Fentanyl Patches in the US as Precaution
February 17, 2008 -- Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group hf, today announced that 14 lots of Fentanyl transdermal system CII patches sold in the United States by Actavis' subsidiary Actavis South Atlantic LLC are being voluntarily recalled from wholesalers and pharmacies as a precaution.
The 14 lots of Fentanyl transdermal system patches being recalled may have a fold-over defect which may cause the patch to leak and expose patients or caregivers directly to the fentanyl gel. Although unaware of any injuries resulting from this issue Actavis, as a precaution, is recalling these lots. As per the approved product labelling for Fentanyl transdermal system, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are leaking or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches that may be damaged or compromised in any way by flushing them down the toilet, using caution not to handle them directly. Damaged and/or compromised patches that have leaked gel will not provide effective pain relief.
Affected patches should not be handled directly. Fentanyl transdermal system is indicated for the management of persistent, moderate to severe chronic pain that requires continuous, around the clock opioid administration for an extended period of time and cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate release opioids.
PRICARA™ RECALLS 25 mcg/hr DURAGESIC® (fentanyl transdermal system) CII PAIN PATCHES
February 12, 2008 – PriCara, Division of Ortho-McNeil-Jansogram/hur mcg/hr)DURAGESrC® (fenoanyl tr(nsderma sy microgram/hour (mcg/hr) DURAGESIC® (fentanyl transdermal system) CII patches sold by PriCara in the United States and all 25 mcg/hr fentanyl patches sold by Sandoz Inc. in the United States are being voluntarily recalled as a precaution from wholesalers and pharmacies. The recalled patches all have expiration dates on or before December 2009, and all are manufactured by ALZA Corporation, an affiliate of PriCara. The recall is being conducted in cooperation with the U.S. Food and Drug Administration. All 25 mcg/hr fentanyl patches manufactured by ALZA and sold in Canada also are being recalled.
DURAGESIC 25 mcg/hr (fentanyl transdermal system) and Sandoz Inc. 25 mcg/hr fentanyl transdermal system patches being recalled may have a cut along one side of the drug reservoir within the patch. The result is possible release of fentanyl gel from the gel reservoir into the pouch in which the patch is packaged, exposing patients or caregivers directly to fentanyl gel. As per the approved product labeling for DURAGESIC, fentanyl is a potent Schedule II opioid medication. Fentanyl patches that are cut or damaged in any way should not be used. Exposure to fentanyl gel may lead to serious adverse events, including respiratory depression and possible overdose, which may be fatal. Anyone who comes in contact with fentanyl gel should thoroughly rinse exposed skin with large amounts of water only; do not use soap. Immediately dispose of affected patches with cut edges by flushing them down the toilet, using caution not to handle them directly. Patches with a cut edge that have leaked gel will not provide effective pain relief.
Anyone who has 25 mcg/hr DURAGESIC or Sandoz Inc. fentanyl patches should check the box or foil pouch for the expiration date to see if they have patches that are being recalled. The recalled patches all have expiration dates on or before December 2009. The cut edge in affected patches can be seen upon opening the sealed foil pouch that holds the patch. Affected patches should not be handled directly.
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