Holtsville, NY

The product is indicated for the temporary relief of minor aches and pains and is packaged in bottles of 120 tablet with NDC 0536-3086-41 and UPC 3 0536-3086-41 9. The affected lot of Enteric Coated Aspirin Tablets is Lot 13A026 with Expiration Date 01-2015. The lot was manufactured and packaged by Advance Pharmaceutical Inc. under the label of Rugby Laboratories. Rugby Laboratories (Major Pharmaceuticals) distributed the product nationwide to wholesalers and retailers.

Consumers may be inadvertently taking Acetaminophen 500 mg instead of Enteric Coated Aspirin 81 mg which may cause severe liver damage to those who take other drugs containing acetaminophen, consumers who take 3 or more alcoholic drinks every day, or those who have liver disease. The labeled directions instructs patients to take 4-8 tablets every 4 hours, but not more than 48 tablets in 24 hours. Consumers who take 48 tablets daily of the defective product may be ingesting up to 24,000 mg of Acetaminophen, which is about six times the maximum recommended daily dose of acetaminophen (4,000 mg).

Advance Pharmaceutical Inc. notified Rugby Laboratories of the recall by e-mail and overnight mail, and is arranging for return of all recalled bottles. Consumers who have the affected lot should immediately discontinue its use and return it to the pharmacy or store where it was purchased. Consumers with questions about the recall may contact Advance Pharmaceutical Inc., Monday-Friday, 9 am- 5 pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Any adverse reactions experienced with the use of this product should be reported to the FDA’s MedWatch Program either by fax, regular mail, or online:

• by Fax at 1-800-FDA-0178

• by Regular Mail: use postage-paid, pre-addressed Form FDA3500 available at http://www.fda.gov/MedWatch/getforms.htm
• Online: http://www.fda.gov/MedWatch/report.htm.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Recall Insider for Recalls

Ingestion of a greater than intended dose of Warfarin, could lead to an increased pharmacological effect of warfarin. As a result, patients would be more likely to develop bleeding as an adverse reaction and in some patients that bleeding into a critical organ (mostly the central nervous system) could be fatal. The risk of bleeding is increased if overdosing is repeated continuously on a daily basis.

Zydus has not received any reports of adverse events or any additional product complaint related to this lot to date, but as a precautionary measure, Zydus is recalling lot MM5767 from the distribution.

The product is used as prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE), prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement and reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. Product is packaged in HDPE Bottle of 1000′s count, which may have been dispensed to patients in smaller bottles. The only lot affected of Warfarin 2 mg Tablets being recalled is Lot MM5767.

The product can be identified by its NDC #6838205310. The product was distributed nationwide in the United States to wholesalers/distributors, retailers and mail order providers, from November 2012 to December 2012.

Zydus has notified its direct account customers by sending the recall notification letter by FedEx next day air service and is working with customers to arrange for product return.

Anyone with an existing inventory of this particular Lot MM5767 of Warfarin 2 mg Tablets should stop use and distribution, quarantine the recalled lots immediately and call INMAR at 1-800-967-5952 between the hours of 7 a.m. to 4 p.m. CST, Monday through Friday, to arrange for their return. In case patients have tablets of this lot of product, make sure all the tablets are of same size and if unsure, patients should consult their dispensing pharmacy.

If you have any question about product safety issue, then please call Zydus Pharmaceuticals Drug Safety/ Medical Affairs at 1-877-993-8779, Option# 2. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this particular lot of Warfarin 2 mg Tablets.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at:
  www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

• Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Recall Insider for Recalls

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The elevated impurity result has the potential to result in prolonged neuromuscular blockade for critically ill patients with renal failure. Sagent is not aware of any adverse patient events resulting from the use of this product to date.

The lot numbers being recalled are (table includes the three lots recalled on June 7, 2013):

Vecuronium bromide is used as an adjunct to general anesthesia, to facilitate endotracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation. The subject lots were distributed to hospitals, wholesalers and distributors nationwide from August 2011 through May 2013. Vecuronium Bromide for Injection is a neuromuscular blocking agent indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation and is supplied in a glass vial.

Sagent’s Distributor DDN is notifying Sagent’s distributors and customers by fax, email and certified mail and is arranging for return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return all recalled lots of the product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at www.Sagentpharma.com.

Any questions about returning unused product should be directed to the customer call center at (866) 625-1618, Monday-Friday, 8am-7pm CST. Healthcare workers who have medical questions about Vecuronium bromide for Injection may contact Sagent Medical Affairs (866-625-1618, Option 3) Monday-Friday, 8am-7pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Program either online, by regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular mail: use postage-paid, pre-addressed Form FDA3500 available at www.fda.gov/MedWatch/getforms.htm
• Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Recall Insider for Recalls

FDA advises that these products may pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.

Bethel 30, green capsules are marketed as a Natural Herb for Weight Loss manufactured with a pharmaceutical & Nutraceuticals laboratory. Bethel 30 Herb Supplement is packaged in plastic white bottles containing 30 capsules per bottle and bears Lot #’s 120514, with EXP: 12/05/2014.

The lot 120514 is the only one subject to recall and it will not be distributed through www.bethel30.com, or retail in office.

The product was sold directly to individual customers in our New York, NY, sales office and online at www.bethel30.com. The company discontinued total distribution. It sincerely regrets any inconvenience to our customers.

No illnesses or injuries have been reported to the company to date in connection with this product. This recall is being conducted with the knowledge of the FDA.

Consumers should not consume Bethel 30, green capsules, Herb Supplement and should return it immediately to the place of purchase for a refund. Consumers with questions should contact Kariny Ramirez 212-568-5330 or via email at customerservice@bethel30.com Monday – Friday, 10:00 am – 4:00 pm, EDT. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

• Fax: 1-800-FDA-0178

Bethel Nutritional Consulting, Inc. is taking this voluntary action because we are committed to the health and safety of our customers and to the quality of our select brand. We are working diligently to make available an appropriate Natural Herbal replacement product manufactured in the USA for all of our affected customers. We are moving forward with new suppliers for our NEW custom formula.

We value our relationship with you and will continue to provide you with the best possible service. Thank you for your continued business and allowing us to be a trusted partner.

Source: FDA

Recall Insider for Recalls

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The elevated impurity result has the potential to result in prolonged neuromuscular blockade for critically ill patients with renal failure. Sagent is not aware of any adverse patient events resulting from the use of this product and is continuing its diligent investigation of the situation.

The lot numbers being recalled are: 11I30481A, 11I30721A and 11I32581A, which were distributed to hospitals, wholesalers and distributors nationwide from January 2012 through May 2012. Vecuronium Bromide for Injection is a neuromuscular blocking agent indicated as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation and is supplied in a glass vial.

Sagent’s Distributor DDN is notifying Sagent’s distributors and customers by fax, email and certified mail and is arranging for return of all recalled product. Customers have been instructed to examine their inventory immediately and to quarantine, discontinue distribution of and return all recalled lots of the product. Customers who may have further distributed this product have been requested to identify their customers and notify them at once of this product recall. The necessary form by which to document this information as well as other information regarding this recall is available at www.Sagentpharma.com.

Any questions about returning unused product should be directed to the customer call center at (866) 625-1618 M-F 8am-7pm CST. Healthcare workers who have medical questions about Vecuronium bromide for Injection may contact Sagent Medical Affairs (866-625-1618, Option 3) M-F 8am-7pm CST.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Program either online, by regular mail or by fax.

• Online: http://www.fda.gov/MedWatch/report.htm
• Regular mail: use postage-paid, pre-addressed Form FDA3500
  available at http://www.fda.gov/MedWatch/getforms.htm
• Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

Recall Insider for Recalls

Name of product:

Target-Mins™ Iron Supplement Bottles

Hazard:

The packaging is not child-resistant as required by the Poison Prevention Packaging Act. The supplement tablets inside the bottle contain iron, which can cause serious injury or death to young children if multiple tablets are ingested at once.

Units

About 1,100

Description

This recall involves Country Life Target-Mins 25 mg iron supplements bottles. The bottle is brown with a black top and has a white label with a yellow banner at the top and a green banner at the bottom. The words “IRON,” “Country Life” and “90 tablets” are printed on the label. Bar code 015794024927 and Lot Number 13A866B are printed on the far left side of the front label.

Incidents/Injuries

None reported

Remedy

Consumers should immediately place recalled bottles out of the reach of children and return them to the place of purchase for a full refund or a replacement bottle.

Sold at

New Seasons, Sprouts Farmers Market, Vitamin Cottage, Whole Foods Market and other natural food stores nationwide from January 2013 to May 2013 for about $10.

Manufacturer

Country Life LLC, of Hauppauge, New York

Manufactured in

United States

Consumer Contact:

Country Life at (800) 645-5768, from 9 a.m. to 6 p.m. ET Monday through Friday, by email at salesadmin@countrylifevitamins.com or visit the firm’s website at www.countrylifevitamins.com and click on the “Contact Us” icon, then “Product Questions” for more information.

Source: CPSC

Recall Insider for Recalls

No adverse events, patient reactions or customer complaints have been reported to date. All customers who received the recalled vials are being notified and instructed to return any unused product to their supplier.

The recalled product is labeled with Product Code 6450 and packaged as 500mg/mL strength in 50mL glass vials (25 vials per tray). The product was shipped in the United States between May 30, 2012 and June 6, 2012 and has an expiration date of October 31, 2014.

Magnesium sulfate is used as electrolyte replacement therapy in the treatment of magnesium deficiency, and as an anticonvulsant to prevent and control seizures in severe toxemia of pregnancy.

The administration of glass particulate, if present in a parenteral drug, poses a potential safety risk to patients. Case reports suggest that sequelae of thromboembolism, some life-threatening (such as pulmonary emboli), may occur. There have also been reports in the literature of particulate possibly causing phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a glass particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material and are typically nonserious. The defect discovered in this product lot was noted as visible particulate.

To report adverse events or quality problems experienced with the use of this product, call Fresenius Kabi USA’s Vigilance and Medical Affairs at 1-800-551-7176, Monday through Friday, between the hours of 8 a.m. and 5 p.m. (CST), or by e-mail appmedicalinfo@APPpharma.com.

Adverse events may also be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Online: www.fda.gov/medwatch/report.htm.

• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 1-800-FDA-0178

Source: FDA

Recall Insider for Recalls

Patients are at increased risk for serious infections in the event a sterile product is compromised. To date Main Street Family Pharmacy, LLC has only received reports of adverse events in three (3) lots of preservative-free methylprednisolone acetate (MPA). At this time, there have been no additional reports of injury or illness associated with the use of our sterile compounded products. Patient safety is our highest priority and, out of an abundance of caution, we have decided to initiate this voluntary recall to include all sterile products. The product list is attached.

These products were supplied to the offices of licensed medical professionals and patients. Sterile products included in this withdrawal were distributed nationwide. Main Street Family Pharmacy, LLC will be notifying customers by phone, fax, email, and/or mail to return the products to the pharmacy. The sterile products include all injectables with the Main Street Family Pharmacy name.

Consumers or Health Care providers with questions regarding this recall may contact Main Street Family Pharmacy, LLC by phone at 731-627-2221 or 888-658-6200 from the hours of 8:30AM-6:00PM Central Standard Time Monday-Friday or email address at msfpcc@bellsouth.net. Patients who have received any sterile compounded product supplied by Main Street Family Pharmacy, LLC and have concerns should contact their healthcare provider.

Adverse reactions or quality problems experienced with the use of sterile compounded products from Main Street Family Pharmacy, LLC may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or fax.

• Online: http://www.fda.gov/MedWatch/report.htm
• Regular Mail: use postage-paid pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm.
  Mail to address on the pre-addressed form
• Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

PRODUCT RECALL LIST

###

Source: FDA

Recall Insider for Recall

Methotrexate is an antimetabolite used in the treatment of neoplastic diseases, severe psoriasis, and rheumatoid arthritis, including polyarticular juvenile rheumatoid arthritis. ¹

Particulate matter in parenteral drugs has been recognized as a potential health hazard. Parenteral injection of drug from the affected lots can lead to microembolisation in areas where the particles lodge. Following intravenous (i.v.) injections, this is in all likelihood the lung. Intrathecal injections are very unlikely with the affected product. In the event of intrathecal administration areas of particle lodging are most likely the areas of spinal fluid resorption. Clinical symptoms are not to be expected from these microemboli. Sandoz is not aware of any reports of related adverse events. Patient safety is our number one priority.

The lot numbers and expiration dates of the two recalled lots are: CL0996 (expiration date 12/2013) and CJ4948 (expiration date 05/2013). These lots were distributed nationally across the US and to a single foreign country (Poland).

In the event that a patient experiences an adverse reaction or quality problem involving this product, they should immediately contact their healthcare professional as well as Sandoz to report the finding. The Sandoz Drug Information Direct Line is open at 800-525-2492, 24 hours/day, seven days a week, or reports can be made via email at qa.druginfo@sandoz.com.

Any adverse reactions or quality problems experienced with the use of this product may be reported to the US Food and Drug Administration’s (FDA) MedWatch Adverse Events Program either online, by regular mail, or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular mail: use postage-paid, pre-addressed Form FDA3500 available at www.fda.gov/MedWatch/getforms.htm
• Fax: 1-800-FDA-0178

¹For full safety information, please see the methotrexate sodium, USP prescribing information, available in the Product Catalog at www.us.sandoz.com.

This recall is being conducted with the knowledge of the US FDA.

Source: FDA

Recall Insider for Recalls

This recall affects only the fifty (50) United States plus the District of Columbia. Distributors and clinical provider sites using these Symbios Medical Products have been notified of the affected product codes and lot numbers. Symbios is working to secure all affected product and have it returned. Products subject to this recall were distributed between April 1^st, 2011 and April 30^th, 2013. Recall action was begun immediately upon the knowledge of the product related issues.

GOPUMP / GOBLOCK KITS SUBJECT TO RECALL

Consumers or using customer sites with questions may contact the company via telephone at 317-225-4447 ext 25 between the hours of 8:00am and 4:00pm.EST. Customers may also contact the company via e-mail at jcarty@symbiosmedical.com.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA:

• Online at http://www.fda.gov/MedWatch/report.htm
• http://www.fda.gov/MedWatch/getforms.htm
  (form available to fax or mail), or
• Call FDA 1-800-FDA-1088

Symbios Medical Products is committed to the highest level of product quality and fully regrets the most recent product related issues. The Board of Directors of Symbios and its Management Team are constantly reviewing programs and processes for product requirements and quality of product in support of pain control of customer’s patients. The expanse of this action is indicative of the company’s desire to insure safe and effective product availability.

Source: FDA

Recall Insider for Recalls

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