Stealth Recalls, European Style

I’ve been complaining recently about Stealth Recalls in the USA – those unpublicized recalls undertaken with FDA knowledge, but without informing consumers.

My complaints notwithstanding, I’m the first to admit that most recalls in the USA are publicized by press release and appear on the FDA or USDA recall web page. Often, they are reposted on various State web sites. In fact, recalls and food safety alerts are far better publicized overall in the USA than in Europe.

Several European governments offer fairly detailed food safety recall and alert information over the Internet – the United Kingdom, the Republic of Ireland, Belgium and Denmark are a few of the best examples. Recently – in the aftermath of last summer’s deadly E. coli O104:H4 outbreak – Germany has begun posting detailed food safety recall information.

The performance of Italy – where the art of cuisine was born – is less than stellar, as witness last year’s botulism episode involving Bio Gaudiano’s Olives Stuffed with Almonds. A jar of this company’s olives was responsible for two cases of botulism in Finland. One of the victims – an elderly woman – died; a second victim from the same household survived.

The manufacturer withdrew all production lots of Almond-stuffed olives from the market last October and expanded the product withdrawn in December 2011 to encompass the entire outstanding stock. While Italian consumers were advised of the initial product recall, their Ministry of Health did not bother informing the population of the expanded recall. Italians had to rely on the Irish and Finnish governments for information on the expanded list of recalled products.

France – the birthplace of Appert, Pasteur, and the science of food preservation – is even worse. Even though the Bio Gaudiano Almond-stuffed Olives were distributed to France, the French government site never notified the public of this botulism-related recall.

France is shockingly lax in its food safety consumer alerts. Last December, I reported on the Salmonella outbreak linked to Label Rouge dried sausage products (manufactured by La Société Salaison Polette ZA). The official recall notice referenced a “strong suspicion” that Salmonella was present in the products. The notification issued to member countries of the European Union (RASFF Notification #2011.1880) referred to a foodborne Salmonella outbreak.

Nor has France turned over a new leaf in the New Year. In February, the French government notified European Union members (RASFF Notification #2012.0265) that a French-manufactured chilled ready-to-eat sausage spread was contaminated with Salmonella. The spread was distributed both in France and in Germany. There was no public notification of the product recall either in France or in Germany, and the manufacturer and brand never were identified.

I have yet to encounter a reasonable justification for withholding this food safety information from the consuming public.

I challenge the Rapid Alert System for Food and Feed to reveal brand names and manufacturers of recalled and withdrawn products – especially ready-to-eat products, and foods that are contaminated with pathogenic microbes.

I challenge France and Italy to match their EU partners – the UK, Denmark, Germany, and even Greece – in alerting the public to food safety recalls and alerts.

And I challenge the US government to take the world lead in improving the dissemination of food safety alerts and recall information.

114 Tons Of Spinach Recalled By Stealth

Thanks to FDA’s weekly Enforcement Report summary, another stealth recall has just seen the light of day.

Leading the list of Class 1 Food recalls in the Enforcement Report for February 8, 2012 is the following item:

PRODUCT
Robert’s S 1 cut leaf spinach; “Curly” spinach. There is no specific type of labeling on the 30 lb totes, except a small sticker label identifying the “pup” container which identifies the harvest date and the field. Field: Robert’s S 1. Harvest Date City: Uvalde, Texas. Farmer: Jimmy Crawford. Pup container #s: “11-21 2011 TIRO TRES FARMS Roberts S1”, “11-22 2011 TIRO TRES FARMS Roberts S1”, “11-23 2011 TIRO TRES FARMS Roberts S1”, “11-25 2011 TIRO TRES FARMS Roberts S1”, “11-28 2011 TIRO TRES FARMS Roberts S1”, “11-29 2011 TIRO TRES FARMS Roberts S1”. Recall # F-0643-2012

CODE
a) 11/28/2011;.11-21 2011; 11-22 2011; 11-23 2011; 11-25 2011; 11-28 2011; 11-29 2011

RECALLING FIRM/MANUFACTURER
Tiro Tres Farms, Eagle Pass, TX, by letters on December 31, 2011. Firm initiated recall is ongoing.

REASON
Product tested positive for E-coli O157:H7.

VOLUME OF PRODUCT IN COMMERCE
228,360 lbs

DISTRIBUTION
CO, KY, MA, PA, and Ontario and Quebec, Canada

If this recall had been publicized – WHICH IT WAS NOT – the news release might have read, “Tiro Tres Farms (Eagle Pass, TX) voluntarily recalls 228,360 pounds of Robert’s S 1 Cut Leaf “Curly” Spinach, due to possible contamination with E. coli O157:H7. The spinach was packed in 30-lb totes, bearing harvest dates of 11/28/2011, 11-21 2011; 11-22 2011, 11-23 2011, 11-25 2011, 11-28 2011 or 11-29 2011 and was distributed in Colorado, Kentucky, Massachusetts, and Pennsylvania. In addition, some of the spinach was shipped to Ontario and Quebec, Canada. The recall was initiated after a sample of the product tested positive for E. coli O157:H7.”

Neither FDA nor Canada’s CFIA (Canadian Food Inspection Agency) carried a notice of this recall.

This recall was initiated by Tiro Tres Farms and announced – ONLY by letters to the company’s customers – on December 31, 2011. The recall is ongoing, and there is no indication in the Enforcement Report whether the spinach was sold by retailers, or how much of the product was actually recovered. By now, of course, the recalled spinach has expired.

As far as I can tell, there were no illnesses associated with the recalled spinach.

I realize that not all recalls are created equal, and that not all recalls require public notification. But I cannot understand the rationale behind NOT publicizing a Class I Hazard recall of a ready-to-eat item of produce that may be contaminated with a potentially lethal pathogen.

Would anyone care to explain this to me?

Novartis Fiasco Affects Pet Meds, Too

The recent shut-down of Novartis Consumer Health’s production facility in Lincoln, Nebraska has affected more than just Excedrin, Bufferin, NoDoz and Gas-X products. Veterinarians and pet owners also have been feeling the impact of Novartis’s abrogation of its quality assurance and product safety responsibilities.

Since issuing its product recall notice on January 8, 2012, the company has twice sent Dear Doctor letters to the veterinary community. The first letter, dated January 10th, warns veterinarians that the temporary suspension of production at the company’s Lincoln, Nebraska plant would affect the availability of certain Novartis Animal Health products. The letter begins:

Dear Valued Customer,

We are writing to inform you that Novartis Consumer Health, Inc. (NCH) has temporarily suspended production and product shipments at one of its manufacturing facilities, an action that will affect the availability of some Novartis Animal Health (NAH) products for the immediate future.

The manufacturing plant products both over-the-counter (OTC) and Animal Health products. NAH brands affected include Interceptor® Flavor Tabs®, Sentinel® Flavor Tabs®, Clomicalm®, Program® Tablets and Suspension, and Milbemite®. Production of Deramaxx, which was recently moved to the site, is also affected, although supplies on hand will continue to be shipped.

The second letter, which is dated January 25, 2012, is headed “IMPORTANT PRODUCT INFORMATION” and reads as follows:

Dear Doctor:

Novartis Animal Health US, Inc. is committed to delivering safe and efficacious veterinary products, and would like to inform you about a recent development involving CLOMICALM® (clomipramine hydrochloride) tablets.

Due to potential packaging issues at our manufacturing facility, there is a rare possibility that a wrong tablet may be found in bottles of CLOMICALM with the enclosed lot numbers. Novartis has not received any reports where a patient experienced a product mix-up, nor has Novartis received any adverse events attributable to a product mix-up. However, as a precautionary measure, we would like to extend the following recommendations.

1) Before dispensing CLOMICALM, open each bottle and examine the contents for tablets that are broken or incorrect in color, shape or size (visual guide included).

2) Post a copy of the Dear Valued Customer letter issued by Novartis Animal Health in your clinic (copy included).

3) Distribute copies of the Dear Valued Customer letter to affected pet owners. Novartis Animal Health will send your clinic extra copies upon request. If you publish a clinic newsletter, please consider using the provided notice.

4) Report any abnormal findings to Novartis Animal Health at 800-637-0281.

5) Return affected product to Novartis Animal Health; call the aforementioned number for full details.

6) Inform your clients who have already received CLOMICALM to examine tablets and refrain from administering any that are questionable in color, shape or size; and to contact Novartis Animal Health to discuss product return of affected bottles.

7) Keep records of communication with pet owners in patient files.

8) Ensure that any re-packaged tablet bottles are labeled with the product lot number.

Novartis Animal Health requests that you complete and return the enclosed Response Card reflecting that you have read and understand these points, and have discussed them with your clients.

Canine separation anxiety is a complex disorder that has great bearing on patient quality of life and the human-companion animal bond. Uninterrupted treatment is essential for successful management of this condition. Our veterinarians are prepared to discuss best practices with you in the event patients require alternative therapies, in order to minimize the risk of adverse events and potential relapse of signs.

We thank you for your attention and cooperation regarding this important issue. If you have any further questions, please contact Technical Product Services and Pharmacovigilance at 1-800-637-0281.

If you are using any of these Novartis Animal Health brands, please keep in close touch with your veterinarian to stay current on supply and quality issues.