Author: Phyllis Entis

CooperVision Revisited

Since January 28, 2011, FDA has received a total of 42 Adverse Event Reports relating to contact lenses.

Twenty-three of these reports specifically complained about Avaira lenses (15 Avaira Toric, 6 Avaire and 2 Avaira sphere). An additional 10 reports cited problems with Proclear lenses; three consumers reported difficulties with Frequency 55 Toric lenses, 2 with Sofmed Breathable Toric Enfilcon A, and one each cited Biofinity CL, Coopervion (sic), and One-day Trueye CL Narafilcon A. One Adverse Report did not provide a brand identification.

Except for the One-day Trueye lenses (a Johnson & Johnson product) and the “unknown” brand, all of the lenses cited by consumers as producing adverse reactions were manufactured by CooperVision.

CooperVision went public with its recall of Avaira® Toric contact lenses on October 13, 2011 – nearly two months after quietly posting a recall notice on its website and alerting its distribution network to the recall.

The company has given no indication of expanding its recall beyond the Avaira® Toric lenses. Yet FDA acknowledges receiving 17 Adverse Event Reports on other CooperVision brands, most notably Proclear and Frequency 55. And several eFoodAlert readers also have reported problems with both Proclear and Frequency 55 contact lenses.

Adverse Event Reports have their limitations. According to FDA’s Morgan Liscinsky, there is no certainty that a reported adverse reaction actually was due to the product cited in a report, and sometimes there are not enough details provided to allow FDA to evaluate an “event” properly.

While these limitations exist, the great preponderance of Adverse Event Reports associated with CooperVision lenses (40 out of 42) seems to defy the laws of random chance.

Nevertheless, FDA has put its stamp of approval on CooperVision’s performance. “CooperVision’s handling of their voluntary recall of Avaira Toric contact lenses,” says Liscinsky, “is consistent with the Agency’s expectations for a Class I recall.”

FDA will continue to monitor the effectiveness of the recall, but gives no indication of pursuing the questions raised about other CooperVision brands. “The FDA,” Liscinsky explains, “does not have any information at this time that would indicate that this voluntary recall would be expanded to include other CooperVision contact lens brands.”

Recalls and Alerts: October 27, 2011

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

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United States

  • Food Safety Recall: Landshire, Inc. (St. Louis, MO) expands its earlier recall of Nike Sandwich to include additional production dates and products, because the sandwiches may be contaminated with Listeria monocytogenes.. The expanded recall includes Landshire Nike All-American Sandwich (7.25 oz/206g; UPC 0 9748801741 5; Production lot codes 11 237 6 through 11 285 6) and Landshire Nike Super Poor Boy Sandwich (2-count pkg (UPC 0 9748800765 2) or 8-count pkg (UPC 0 9748800712 6); Production lot codes 11 237 6 through 11 285 6). The recalled sandwiches were distributed nationwide at convenience stores, wholesale food distributors and retail supermarkets, including Ralphs and Walmart.
  • Food Safety Recall/Outbreak Alert: Wegmans Food Markets, Inc. recalls Turkish Pine Nuts sold in the Bulk Foods department of Wegmans stores in New York, Pennsylvania, New Jersey, Virginia and Maryland between July 1 and October 18, 2011, after consumption of the pine nuts was linked to 42 confirmed cases of Salmonella Enteritidis infections in six states.
  • Food Safety Recall: Judy’s Catering, LLC (Burbank, CA) recalls ready-to-eat meals produced on 4/27/11, 6/15/11, 8/10/11, 9/12/11, or 9/13/11, because they were produced without the benefit of federal inspection. The ready-to-eat meals were sent to distribution centers in the Los Angeles County area, and may have been sold to airlines and hospitals. The recalled products carry expiration dates of 10/27/11, 12/15/11, 2/10/12, 3/12/12 or 3/13/12.
  • Food Safety Recall: A.L. Bazzini recalls Honey Nut & Seed Crunch (all lots) and Honey Nut & Seed Crunch Mix (all lots), due to possible foreign material in the product, according to a notice posted by Giant Eagle.
  • Outbreak Alert: The Saint Louis County Department of Health is investigating an outbreak of shiga toxin-producing E. coli that has sickened 14 people so far this week. The outbreak victims range from 4 to 94 years of age, and have been suffering from bloody diarrhea, according to a report on stltoday.com. The Missouri Department of Health and Senior Services is assisting in the lab analysis and in the outbreak investigation, and has notified CDC.

Canada

  • Allergy Alert: McCormick Canada Co. (London, ON) recalls McCormick International Roast Gravy Sauce Mix (32g; UPC 0 66200 90556 9; Date codes 1214A, 1214B, 1214C and 1215C), because the product may contain undeclared milk. The recalled sauce mix was distributed nationally.
  • Food Safety Recall: Viande Richelieu Inc. recalls Viande Richelieu Horse Meat Deboned (Code 1237), Ground (code 1242) and Sliced (Code 1244), due to the presence of drug residues in the meat. The recalled horse meat was distributed to retailers in the province of Québec.

Europe

  • Pharmaceutical Product Safety Recall: Apotex SPAIN SL recalls OLANZAPINA APOTEX 15MG 28 COMPRIMIDOS BUCODISPERSABLES EFG (Product of Apotex Inc (Canada); Lot JW5630; Expiry date 30/04/2013), due to the presence of 10mg blisters inside some containers.

Australia and New Zealand

  • Food Safety Recall (Australia): Murray Goulburn Company Ltd. recalls Devondale UHT Skim Milk (2L tetra brik pkg; Best Before 05 June 12-3; Batch code 06:08 to 07:08), due to bacterial spoilage in some packs. The recalled milk was sold in Coles Supermarkets nationwide, in IGA stores in West Australia and Queensland, and at the Murray Goulbourne Trading Store in Corryong, VIC.
  • Food Safety Alert (West Australia): The public is reminded not to eat shellfish collected from within the Peel-Harvey Estuary (South of Mandurah), or wild shellfish from elsewhere in West Australia, due to the presence of algae that are capable of causing Diarrhetic Shellfish Poisoning.

Latin America and the Caribbean

  • Medical Device Safety Recall (Brazil): Bayer SA recalls Countour TS Test Strips for Blood Glucose, because under certain conditions, some test strips can produce a falsely low blood glucose reading.

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket’s recall web site.

*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains, listed on the Kroger corporate home page.
**Includes Safeway, Vons, Pavilions, Dominick’s, Genuardi’s, Randalls, Tom Thumb, Carrs and Pak N’ Save.

Pine Nuts From Turkey Behind New Salmonella Outbreak

Pine nuts imported from Turkey by Sunrise Commodities (Englewood Cliffs, NJ) and sold in Wegmans supermarkets have been identified as the source of a strain of Salmonella Enteritidis that has infected 42 people in six US states.

CDC reports that the illnesses, which began on August 20, 2011, have been reported in Arizona (1), Maryland (1), New Jersey (2), New York (26), Pennsylvania (8) and Virginia (4). Two people were hospitalized.

Sixty-three percent (63%) of the 30 outbreak victims for whom information is available reported having eaten Turkish pine nuts, or products containing them, during the week before they became ill. Among the prepared foods identified as containing the contaminated pine nuts were Caprese salad or asparagus with pine nuts, sold at Wegmans stores. The CDC report is unclear whether these prepared foods were purchased ready-made from Wegmans stores, or whether they were home-prepared using pine nuts purchased at Wegmans.

The Salmonella Enteritidis outbreak strain was recovered by the Virginia Division of Consolidated Laboratory Services from Turkish pine nuts purchased from a Wegmans bulk bin and collected from a patient’s home, and from samples of Turkish pine nuts obtained directly from a Wegmans store. New York found Salmonella Enteritidis in two separate samples of homemade pesto containing the implicated pine nuts, as well as from a Wegmans store in that state and from pine nuts collected from a New York patient’s home. The Salmonella recovered from the pesto samples is identical to the outbreak strain.

Today, Wegmans Food Markets Inc. (Rochester, NY) recalled approximately 5,000 pounds of Turkish Pine Nuts sold in the bulk food departments of Wegmans stores in New York, Pennsylvania, New Jersey, Virginia and Maryland between July 1, and October 18, 2011.

Pine nuts have a fairly long shelf life, and may linger in consumers’ homes – either plain or as an ingredient in a pesto or prepared meal – for a long time after the retail recall is complete. CDC offers the following advice:

  • Consumers should check their homes, including refrigerators and freezers, for Turkish pine nuts purchased from bulk bins at Wegmans stores between July 1, 2011 and October 18, 2011 and not eat them. Consumers should also not eat any foods prepared with the recalled product, including pesto, salads, and baked goods.
  • Restaurants and food service operators should not serve the recalled product.
  • Consumers, retailers, and others who have any of the recalled product should dispose of it in a closed plastic bag placed in a sealed trash can. This will prevent people or animals from eating it.
  • Persons who think they might have become ill from eating possibly contaminated recalled products should consult their health care providers. Infants, older adults, and persons with impaired immune systems are more likely than others to develop severe illness.