Fraudulent Botox found in Supply Chain [US]

United StatesUS/Silver Spring: The US Food and Drug Administration (“FDA”) issues Health Alert after fraudulent versions of Botox found in the United States. MDs, healthcare providers and patients are asked to report suspect versions of the drug. FDA: http://ht.ly/kLtFP

Direct link: http://www.fda.gov/Drugs/DrugSafety/ucm349503.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the outer carton of the fraudulent version is counterfeit, while the vial inside is labeled as a foreign version of Botox. This foreign version is not FDA-approved for sale in the United States. According to the FDA, these drugs are being sold by unlicensed suppliers who are not part of the legitimate US supply chain. FDA cannot confirm that the manufacture, quality, storage and handling of these products follow US standards. These fraudulent products are considered unsafe and should not be used.

The FDA says the company selling the fraudulent versions of Botox goes by the names “Online Botox Pharmacy”, “Onlinebotox.com” and “Onlinebotox”. At the time this alert was issued, the company did not appear to be selling its products over the internet. Instead, the company has been using “blast faxes” to solicit sales from medical practices, typically selling products at prices below those of FDA-approved products. As is the case with many companies that sell fraudulent products, Online Botox Pharmacy uses a US return address when sending packages to medical practices, even though the products are from foreign sources.

The FDA reports medications purchased from foreign or unlicensed sources may be misbranded, adulterated, counterfeit, contaminated, improperly stored and transported, ineffective and/or unsafe. Medical practices that purchase and administer illegal and unapproved medications from foreign sources are putting patient health at risk, as patients may not be getting proper treatment.

FDA-approved Botox for injection (100 units/vial), manufactured by Allergan, displays the active ingredient as “OnabotulinumtoxinA” on the outer carton and vial. Currently, there is no indication that Allergan’s FDA-approved version is at risk, and this product should be considered safe and effective for its intended and approved uses.

Suspect fraudulent products can be identified as follows:

  • the outer carton displays the active ingredient as “Botulinum Toxin Type A”; or
  • the lot numbers and expiration dates on the outer carton and accompanying vial do not match.

Thus far, the following examples have been confirmed as fraudulent Botox. Products with any of these lot numbers and expiration dates should be considered suspect.

Example 1
Lot #C3016 C3 (carton); Exp Date: 10-2014
Lot #C3121 C3 (vial); Exp Date: 04-2015

Example 2
Lot #C3060 C3 (carton); Exp Date: 01-2015
Lot #C3121 C3 (vial); Exp Date: 04-2015

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Recalls Direct RIN: 2013-1954
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E. & O. E.

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Natura Pet Food Recall Expands [Canada]

Canadian FlagCanada/Ottawa: Natura Pet Products expands existing recall for various brands of Dry Pet Food due to Salmonella hazard. HCSC: http://ht.ly/kLhim

Direct link: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/28999r-eng.php

Additional information:
Health Canada/Santé Canada (“HCSC”) reports this recall already involves the following brands of Dry Pet Foods with an expiration date prior to and including March 24, 2014:

  • Innova
  • EVO
  • California Natural
  • HealthWise
  • Karma

Additionally, the expanded recall now includes EVO treats and Innova Cat treats with an expiration date prior to and including March 24, 2014. For a complete list of the specific products affected by this recall, please consult the firm’s website here: http://www.naturapet.com/recall

 

About Salmonella Poisoning in Animals:
Salmonellosis (Salmonella poisoning) is a very common type of food poisoning caused by the Salmonella bacterium. According to the US Food and Drug Administration, animals with Salmonella infections may be lethargic and have diarrhea or bloody diarrhea, fever and vomiting. Some animals will have only decreased appetite, fever and abdominal pain.

It is important to note that infected but otherwise healthy looking animals can be Salmonellosis carriers and infect other animals or humans through various routes including oral-manual, oral-oral and oral-fecal. Always wash your hands thoroughly after feeding, petting or performing other activities with animals, especially those relating to waste elimination and disposal of fecal matter.

You can learn more about Salmonellosis from Health Canada at: http://ht.ly/eRVGG

HCSC recall number: RA-28999
Recalls Direct RIN: 2013-1952
About the RecallsDirect service: http://wp.me/P2bVty-2
Visit the Living Safely site: http://www.livingsafely.org/
E. & O. E.

Donatello’s, Zia Maria Frozen Pizza Recall [Canada]

Canadian FlagCanada/Ottawa: RFG Canada recalls some Frozen Pizzas due to undeclared mustard, a known allergen. CFIA: http://ht.ly/kKQak

Direct link: http://healthycanadians.gc.ca/recall-alert-rappel-avis/inspection/2013/29017r-eng.php

Additional information: The Canadian Food Inspection Agency (“CFIA”) reports the following Frozen Pizzas are subject to this recall:1952 - DonatelloPizza

  • Donatello’s Rizin’ Crust – Pepperoni Bake & Rise Pizza; 715 g; UPC: 7 76808 01112 7
  • Zia Maria Pepperoni Rising Crust Pizza, 840 g; UPC: 7 74223 23956 0
  • Zia Maria Deluxe Rising Crust Pizza, 927 g; UPC: 7 74223 23957 7

About Mustard Allergies:
For some people, mustard (and mustard products) are a source of urgent, dangerous and potentially deadly, allergic reactions requiring immediate medical intervention and treatment. Anaphylactic Shock could occur in consumers who are allergic to foods containing mustard within a very short time, potentially leading to severe injury and/or death. If you suspect Anaphylactic Shock, call 9-1-1 or other local emergency number for immediate transport to a medical center.

If trained and an emergency kit is available, it may be appropriate to give an injectable drug such as Epinephrine (also known as adrenaline or adrenalin) to the affected individual. Trade names of these products include EpiPen, Twinject, Adrenaclick, Anapen, Jext, Allerject and Auvi-Q. Please note: even patients who are apparently stabilized should still go to hospital for emergency evaluation. Further treatment is often necessary.

You can learn more about Mustard Allergies by visiting Health Canada at http://ht.ly/keZ4J

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Recalls Direct RIN: 2013-1952
About the Recalls Direct service: http://wp.me/P2bVty-2
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E. & O. E.

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EU Issues 37 Product & Vehicle Recalls

FlagEUBelgium/Brussels: European Union issues 37 new consumer-based product recalls; a must-read for parents, caregivers, drivers and others: http://ht.ly/kIuh3 

Direct link: http://ec.europa.eu/consumers/dyna/rapex/create_rapex.cfm?rx_id=520

The European Union reports the following Consumer Products and/or Vehicles (in alphabetical order) are subject to this recall:

  • Aguila de Oro Toys Juguete de Madera Pull-Along Toy – Choking hazard
  • Aguila de Oro Toys Rattle Maracas – Choking hazard
  • Alex Bog Children’s Plastic Animal Toys – Chemical, choking hazards
  • Avocado Aeroplane Lamp – Electric shock hazard
  • Best brand Notebook – Chemical hazard
  • Bibita Children’s Tracksuit Trousers – Injury hazard
  • Brum Beby Children’s Tracksuit – Injury, strangulation hazards
  • D’ an Dian Rechargeable Torch – Fire, electric shock hazards
  • Etemoglu Children’s Dress – Injury hazard
  • Growing Pet “Hatch’em” brand Growing Pet Dinosaur Egg Toy – Choking hazard
  • Haroma Children’s Sandals – Choking hazard
  • Henna Natural Hair Dye – Microbiological hazard
  • Honda Stream, CR-V, Civic, Jazz, Odyssey Vehicles – Injury hazard
  • Hong Feng Toy Children’s Happy Garden Toys – Burns, chemical and choking hazards
  • Jumbo Tow Rope – Injury hazard
  • Jummy Kids Children’s Shoes – Choking hazard
  • Jump & Fish Children’s Coat – Strangulation hazard
  • KTM 85 SX, 150 SX, 250 SX, 250 EXC and 300 EXC Motorcycles – Injury hazard
  • Last Star Children’s Clothing Set – Injury, strangulation hazards
  • Mountain brand Girls’ Boots – Choking hazard
  • Non-Branded 100 Christmas Light Lighting Chain – Fire, electric shock hazards
  • Non-Branded Children’s Pirate Set Clothing – Chemical, environmental hazards
  • Non-Branded Children’s Plastic Figure Toys – Chemical, environmental hazards
  • Non-Branded Lighting Chain – Fire, electric shock hazards
  • Non-Branded Plastic Ducks – Chemical hazard
  • Non-Branded Plush Dice – Choking hazard
  • Non-Branded Princess Plastic Doll – Chemical hazard
  • Novum Leder Mini Bikini Extreme Passions Bikini – Chemical hazard
  • Peng Sheng Hannah Montana Mobile Telephone Toy – Chemical hazard
  • Pepperts! Kinder Leder Boots – Chemical hazard
  • Peugeot 208 Passenger Car – Injury hazard
  • Safety brand Reflective High Visibility Stickers – Injury hazard
  • Sante Hair Dye – Microbiological hazard
  • V&F Happy Girl Plastic Doll Toys – Chemical hazard
  • Volvo Penta Inboard Marine Engine – Fire hazard
  • Yesmina Girls’ Clothing Set – Strangulation hazard
  • YIMA Portable Radio – Electric shock hazard

EU RAPEX Report: 17/2013
Recalls Direct RIN: 2013-1951
About the RecallsDirect service: http://wp.me/P2bVty-2
Visit the Living Safely site: http://www.livingsafely.org/
E. & O. E.

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