Category: recalls

Botulism Alert – Finland, Germany, United Kingdom and USA

Italian olives tainted with botulinum toxin sickened two members of a Helsinki family last week.

Both individuals reported having eaten Gaudiano Organic Olives Stuffed with Almonds. Lab tests confirmed that the jar from which the two patients had eaten the olives contained botulinum toxin.

The tainted olives were packed in 314ml glass jars, with a best before date of 09/2012. They were imported into Finland by Kespro as early as September 2010. The olives were sold in Finland to K-food stores KCM Big Apple (Espoo), KCM Jumbo (Vantaa) and KSM South Centre (Rovaniemi), and to a few restaurants.

The olives have been withdrawn from sale in Finland, and consumers who purchased this product are asked to return it to the store.

Germany’s Federal Office for Consumer Protection and Food Safety has learned that some of these olives also were distributed in Germany, and is asking its citizens to dispose of any of the implicated jars of olives “with household waste”.

According to a notice posted October 21, 2011 on the Rapid Alert System for Foods and Feeds (RASFF) and updated this morning (October 24th), these olives also were distributed to the United Kingdom and the USA. So far, neither the U.S. Food and Drug Administration nor Britain’s Food Standards Agency has issued a Consumer Alert or a public health advisory of any sort.

eFood Alert Advisory to Consumers in Finland, Germany, the United Kingdom and the USA:

Check your pantry for Gaudiano Organic Olives Stuffed with Almonds (Product of Italy; Best before 09/2012), and discard the product in a safe manner. DO NOT TASTE THIS PRODUCT. If you have consumed even a tiny amount of this product and begin to experience any symptoms of botulism, including blurred vision or difficulty swallowing, seek immediate medical attention.

CooperVision Avaira® Toric Recall Goes Public

October 14, 2011.- Today – almost two months after issuing a “recall notification letter” to its US and Canadian distributors and health care practitioners, CooperVision’s recall notice finally appeared on FDA’s website.

The essential details of the formal recall notice are as follows:

  • Recall Class: Class I (Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.)
  • Date Recall Initiated: August 19, 2011
  • Product(s): AVAIRA Toric (enfilcon A) TORIC soft (Hydrophilic) Contact Lenses, 6 Soft Contact Lenses for Astigmatism. The lenses were manufactured from November 1, 2010 through August 3, 2011. Consumers wanting to determine whether their lot code was recalled can use the search box on the CooperVision recall web page at http://www.coopervision.com/recall or call the toll-free consumer hotline at 1-855-526-6737.
  • Reason for Recall: The unintended presence of a silicone oil residue on lenses from certain lots of Avaira Toric contact lenses. Symptoms may range from hazy, blurry vision, discomfort to eye injuries requiring medical treatment.

Please refer to the Recall Notice for additional information and instructions.

As I reported yesterday, FDA has received a total of 42 “adverse reaction” reports from contact lens wearers. Only 15 of those 42 reports were associated with Avaira® Toric contact lenses. According to FDA spokeswoman Morgan Liscinsky, several other brands manufactured by CooperVision have been the subject of consumer complaints, including Frequency 55 Toric, Proclear, Sofmed, and Enfilcon A contact lenses.

Several eFoodAlert readers also have reported eye discomfort and injuries associated with wearing Frequency 55 and Proclear contact lenses, in addition to many others who experienced corneal abrasions after wearing Avaira Toric lenses.

While I am pleased and relieved to see that CooperVision finally has consented to issue a Class I Recall Notice, I can’t help wondering whether this would have happened without the story published by JoNel Aleccia of msnbc.com on October 11th.

I also wonder how much more time must pass before CooperVision acknowledges that their problem extends beyond the Avaira Toric brand.

CooperVision’s Avaira Lenses – Only 40% Of The Problem?

Less than 40% of the adverse reports FDA has received on contact lenses involve Avaira® Toric lenses, eFoodAlert learned today.

The FDA’s Office of Surveillance and Biometrics has received a total of 42 adverse reports, according to FDA spokeswoman Morgan Liscinsky, and only 15 of those were associated with Avaira® Toric lenses. Ms. Liscinsky, who was responding by email to an earlier inquiry, did not identify which other brands (or manufacturers) have been named in adverse reports.

CooperVision recalled some lots of Avaira® Toric contact lenses on August 19, 2011 and reiterated its recall notice on October 12th, but has not acknowledged any problems with its other contact lens brands.

Based on reports that eFoodAlert has received from our readers, these other brands may include Frequency55, Proclear and UltraFlex contact lenses. Earlier today, I provided a consolidated list of these adverse reports both to FDA and to CooperVision.

As of yesterday, FDA was still evaluating CooperVision’s latest notification. The agency “…will advise Coopervision of any concerns that [the notification] raises,” Liscinsky explained in an email message. “Failing resolution of those concerns,” she added, “the FDA may issue separate public communication.”

Personal injury attorneys, though, aren’t waiting for FDA to act. At least one firm of ambulance-chasers already is soliciting clients.

It’s past time for FDA to focus public attention on this problem by issuing a broad Consumer Alert.