Soliris (eculizumab) IV Infusion Recall Update [US]

US FDA RecallUS/Silver Spring: Alexion Pharmaceuticals updates existing recall for some Soliris (eculizumab) Concentrated Solution for Intravenous Infusion due to particulate hazard. FDA: http://ht.ly/rUZvp

Direct link: http://www.fda.gov/Safety/Recalls/ucm378614.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Drugs are subject to this recall: Continue reading

Tesco 4 Chocolate & Nut Ice Cream Cone Recall [UK]

UK FSA RecallUK/London: Tesco recalls some 4 Chocolate & Nut Ice Cream Cones due to added pain relief tablet hazard. FSA: http://ht.ly/rdWBz

Direct link: http://www.food.gov.uk/news-updates/recalls-news/2013/nov/tesco-cones

Additional information:
The UK Food Standards Agency (“FSA”) reports the following Ice Cream Cones are subject to recall: Continue reading

Nature’s Pharmacy Sterile Compounded Product Recall [US]

US FDA RecallUS/Silver Spring: Nature’s Pharmacy and Compounding Center recalls all Sterile Compounded Products distributed within North Carolina due to lack of sterility assurance, a health and safety hazard. FDA: http://ht.ly/r1Wpj

Direct link: http://www.fda.gov/Safety/Recalls/ucm375358.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Compounded Drugs are subject to this recall: Continue reading

Bodico Hand Sanitizer Recall [Canada]

Canada HCSC RecallCanada/Ottawa: Health Canada recalls some Bodico Hand Sanitizer due to undeclared methanol hazard; two deaths reported. HCSC: http://ht.ly/q9RmZ

Direct link: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/36469a-eng.php

Additional information:Bodico Hand Sanitizer
Health Canada/Santé Canada (“HCSC”) reports the following Personal Care Products are subject to this recall:

  • Bodico Hand Sanitizer, 8 fluid ounce pump container, lot B9002
  • Bodico Hand Sanitizer with Aloe and Vitamin E, 8 fluid ounce pump container, lot B9001

Health Canada reminds all consumers that the labels of hand sanitizers advise external use only and as such, the product should never be ingested. Testing undertaken by the province of Ontario’s Centre of Forensic Sciences of two bottles of Bodico Hand Sanitizer associated with the deaths found the product contained methanol, an undeclared ingredient, and not ethyl alcohol, the active ingredient actually listed for the product. Methanol is a highly toxic alcohol that, if ingested, can cause blindness or death. High amounts of methanol applied to the skin can cause irritation and inflammation.

Health Canada is working with the company that makes Bodico Hand Sanitizer and is in the process of independently testing additional samples of the product.

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HCSC ID number: 36469
Recalls Direct RIN: 2013-2658
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Curried Lentil Casserole Recall [Canada]

Canada CFIA RecallCanada/Ottawa: Healthcare Food Services recalls some Curried Lentil Casserole due to extraneous material hazard. CFIA: http://ht.ly/lTMWU

Direct link: http://healthycanadians.gc.ca/recall-alert-rappel-avis/inspection/2013/34009r-eng.php

Additional information:
The Canadian Food Inspection Agency (“CFIA”) reports the following Food is subject to this recall:

  • Healthcare Food Services Curried Lentil Casserole, 8 x 260 gram packages; Day Codes: 3035, 3045, 3063, 3077, 3084, 3101; UPC codes: (01) 1 0062373 99596 0

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CFIA ref: 8000
Recalls Direct RIN: 2013-2107
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Visit the Living Safely site: http://www.LivingSafely.org
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Main Street Family Pharmacy Compounded Product Recall [US]

United States FlagUS/Silver Spring: Main Street Family Pharmacy of Newbern, Tennessee recalls all lots of All Sterile Products compounded by the pharmacy due to microbial hazard. FDA: http://ht.ly/lvlik

Direct link: http://www.fda.gov/Safety/Recalls/ucm354182.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the Compounded Products subject to this recall are those products with a Use By Date on or before November 20, 2013. The recall was initiated after seven (7) reported cases of adverse events in the form of skin abscesses, one of which appears to be fungal in nature. An investigation into the exact source of the adverse events remains ongoing.

Recalls Direct RIN: 2013-2044
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Visit the Living Safely site: http://www.LivingSafely.org
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Hospira 0.9% Sodium Chloride Injection Recall Update [US]

FlagUSUS/Silver Spring: Hospira updates its previous recall for some 0.9% Sodium Chloride Injection Solution, USP, 100 mL due to particulate matter hazard. FDA: http://ht.ly/kINjA

Direct link: http://www.fda.gov/Safety/Recalls/ucm349552.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports this recall updates its original notification in which four separate particulate issues were identified in four individual flexible containers. The four single particles were identified as follows: polyester fiber, nylon fiber, cotton fiber and nitrocellulose fiber, respectively.

The FDA says this product is used as a source of water and electrolytes and is packaged in a 100 mL flexible container, lot number 05-201-JT (the lot number may be followed by a -01). The recalled product has an expiration date of May 1, 2013, and was distributed within the United States between May 2011 and August 2011 to wholesalers/distributors, hospitals and pharmacies.

Recalls Direct RIN: 2013-1947
About the Recalls Direct service: http://wp.me/P2bVty-2
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