Category: recalls

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.

FDA Inspection Report Slams Novartis Inaction

“As of 12/12/11, your firm is overdue (untimely) with adequately conducting approximately 1,360 investigations you have received from consumer complaints (1332 are major, 31 are critical). This backlog of overdue complaints has been over 1,000 in number since at least 8/30/11.”

– FDA to Novartis Consumer Health (Lincoln, Nebraska), January 20, 2012

FDA has just released (January 30, 2012) a scathing 23-page Inspectional Observations (Form 483) report, which the agency issued to Novartis Consumer Health ten days ago, following completion of a reinspection of the company’s Lincoln, Nebraska facility.

The inspection report details numerous examples of egregious and unconscionable disregard for consumer safety on the part of Novartis Consumer Health – many of them issues that remain unaddressed since the facility was inspected last July. Consumer complaints of product mix-ups and chipped tablets have either not been investigated, or the investigation was inadequate, incomplete or delayed.

Some of the most flagrant deficiencies highlighted in the latest FDA report include:

  • As of 12/21/11, your firm … has approximately 360 consumer returned complaint samples of various products (major and critical complaints) that have not been thoroughly reviewed by your Quality Unit. … [The problems] requiring investigation include, but are not limited to: foreign product, foreign object, suspected tampering, chipped/cracked/crumbled tablets, broken/missing seal, etc. … Your firm is outside of procedural timeframes for completing approximately 340 open Corrective and Preventative Action requirements … and 48 deviation … investigations.
  • [I]nvestigation fails to address how “28 assorted tablets” (some not packaged in the room, such as Gas X, Soft Gels, etc) could have entered a room dedicated to packaging other products.
  • [I]nvestigation, opened 11/18/11 and closed 12/16/11, into a complaint for “12 extra tablets”, found by a pharmacist after opening a sealed bottle of Morphine Sulfate ER 30mg… is deficient. … This is important because this consumer complaint was recently closed and is indicative of how your firm is currently investigating consumer complaints.
  • Your most recent consumer complaint (opened 12/16/12 and closed 12/20/11) into Bufferin RS Tablets, Lot: 10095189, for partial/incomplete tablet caplets, dues not address all lots of product potentially affected by the problem of over-compressed tablets identified as the root cause. Your firm was aware of Partial/Incomplete Bufferin tablets/caplets issues since at least 2009, yet a Medical safety Assessment Report was not released until 10/14/11. There is no justification or explanation for the approximate 2 year delay in obtaining this report.
  • There is not root cause identified for the foreign tablets potentially in a Prevacid 15 MG Capsule container. … You have had 35 mixed tablet/foreign products for Prevacid 15 mg Capsules since 2009.
  • It is important to understand because of your firm’s failure to adequately and thoroughly conduct investigations, it is difficult to determine how widespread the problems are at your firm…
  • Your packaging line clearance operators failed to adequately clean packaging lines (and areas around packaging lines) during your “major” cleaning efforts of this equipment…
  • Your most recent Annual Product Review (APR) for Bufferin Extra Strength Tablets and Bufferin Regular Strength Tablets (2010) is incorrect. …
  • Your most recent 2011 Annual Product Review for Excedrin Extra Strength Express Gels … approved 5/27/11, is deficient. The report fails to document the consistent trend of complaints received by your firm for “Product Chipped, Cracked, Crumbled” and “Partial/Incomplete Tablet/Caplets” regarding this product. … Your firm has been aware of “Product Chipped, Cracked, Crumbled” and “Partial/Incomplete Tablet/Caplets” for this product (Express Gels) since at least 2009, yet a complete market correction (due to this problem) was not executed until 1/8/12, which occurred during the course of this FDA inspection.
  • The conclusion in your most recently completed 2011 Annual Product Review for Benefiber Plus Calcium Powder, signed as acceptable on 6/27/11, is not supported by the information in the report.
  • You have failed to document the root cause, and implement effective corrective and preventative actions, regarding product mix-up complaints for solid dosage form foreign tablets of products manufactured at your firm since at least 2009. (Referring to products such as: Excedrin family products, Prevacid, narcotic products, etc… Your foreign product recall assessment, dated 10/17/11, states you have received approximately 70 confirmed, returned customer complaint, mix-up samples containing only NCH-Lincoln produced product. In total, There have been 400 complaint cases of this type since 2009.
  • There is an inadequate number of Quality Unit personnel in your firm to conduct timely, correct and thorough reviews of the products you manufacture.

And, repeated over and over again throughout the 23-page report, is the statement – highlighted BY THE FDA INSPECTOR in upper case and bold-face:

THIS IS A REPEAT VIOLATION FROM THE PREVIOUS INSPECTION AT YOUR FIRM DATED 6/13-7/8/11

I would not be surprised to see another recall announcement from Novartis Consumer Health – one that covers all products manufactured by the company since 2009 at its Lincoln, Nebraska production plant.