Sagent Pharmaceuticals Expands a Nationwide Voluntary Recall to All Lots of Vecuronium
Bromide for Injection, 10mg Single Use Vials Manufactured by Mustafa Nevzat (MN Pharmaceuticals)

Contact
Consumer:
(866) 625-1618

Media Contact:
Jonathon Singer
(847) 908-1605
jsinger@sagentpharma.com
 

FOR IMMEDIATE RELEASE – June 13, 2013 – Sagent Pharmaceuticals, Inc. today announced the expanded voluntary nationwide recall of Vecuronium Bromide for Injection 10mg (NDC number 25021-657-10) manufactured by Mustafa Nevzat Ilac Sanayii A.S. (MN Pharmaceuticals) and distributed by Sagent. Sagent initiated a voluntary recall of Vecuronium Bromide for Injection to the user level for three lots on June 7, 2013 due to the discovery of an elevated impurity result detected during routine quality testing of stability samples at the 18-month interval. Based on the results of additional analyses conducted since the initial recall, Sagent expanded its recall of Vecuronium Bromide for Injection, 10mg to the user level to include all lots manufactured between July 2011 and May 2012.

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):

Lot No. Exp. Date Lot No. Exp. Date Lot No. Exp. Date
11F23921A Jul-13 11K36761A Oct-13 12B04871A Feb-14
11G24001A Jul-13 11K37451A Oct-13 12B04921A Feb-14
11G24251A Jul-13 11K37471A Oct-13 12B06501A Feb-14
11G24471A Jul-13 11K38171A Oct-13 12B06741A Feb-14
11G24701A Jul-13 11L40161A Nov-13 12C09031A Mar-14
11G25051A Jul-13 11L40201A Nov-13 12C09041A Mar-14
11G25471A Jul-13 11L40891A Nov-13 12C09301A Mar-14
11G24341A Jul-13 11L40781A Nov-13 12C09461A Mar-14
11I30521A Sep-13 11L40851A Nov-13 12C09471A Mar-14
11I31651A Sep-13 11L40921A Nov-13 12C11641A Mar-14
11I31661A Sep-13 11L42961A Nov-13 12D12401A Apr-14
11I30481A Sep-13 11M44271A Dec-13 12D12761A Apr-14
11I30721A Sep-13 11M44371A Dec-13 12D12861A Apr-14
11I30731A Sep-13 11M44381A Dec-13 12D13061A Apr-14
11I32581A Oct-13 11M45041A Dec-13 12D13351A Apr-14
11K34241A Oct-13 11M45421A Dec-13 12D13361A Apr-14
11K34471A Oct-13 11M45641A Dec-13 12D13401A Apr-14
11K35861A Oct-13 12A02161A Jan-14 12E15981A May-14

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.com1.

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.

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

About Sagent Pharmaceuticals, Inc.
Sagent Pharmaceuticals, Inc., founded in 2006, is a specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, with a specific emphasis on injectables. Sagent has created a unique global network of resources, comprising rapid development capabilities, sophisticated manufacturing and innovative drug delivery technologies, resulting in an extensive and rapidly expanding pharmaceutical product portfolio that fulfills the evolving needs of patients.

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Bethel Nutritional Consulting, Inc. Issues a Voluntary Recall of Weight
Loss Pills “Bethel 30” Found to Contain an Undeclared Drug Ingredient

Contact
Consumer:
212-568-5330
customerservice@bethel30.com
 

FOR IMMEDIATE RELEASE – June 11, 2013 – Bethel Nutritional Consulting, Inc. was informed by the Food and Drug Administration (FDA) that a sample of Bethel 30 green capsule was collected and tested by FDA in April 24, 2013. The capsules tested positive for Sibutramine and Phenolphthalein. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The FDA has not approved Bethel 30, green capsules as drugs; therefore the safety and effectiveness of this product is unknown.

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.com1, or retail in office.

The product was sold directly to individual customers in our New York, NY, sales office and online at www.bethel30.com2. 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.

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.

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Zydus Pharmaceuticals USA Inc. Issues Voluntary Nationwide Recall of Warfarin 2 mg Tablets, Lot MM5767, Expiration Date June 2014, Due to Oversized Tablets

Contact:
Consumer:
Zydus Pharmaceuticals USA Inc.
1-877-993-8779, Option #2
 

FOR IMMEDIATE RELEASE – June 10, 2013 – Zydus Pharmaceuticals USA Inc. is voluntarily recalling one lot of Warfarin 2 mg Tablets, Lot #MM5767, expiration date June 2014 to the retail level. Four tablets of Warfarin 2 mg Tablets, Lot MM5767, have been found to be oversized in one product complaint.

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.

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

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Source: FDA.gov

Reblogged: 6/14/13 1430 PST