Last Update: August 07, 2003
Warning Letter Issued to Importer
Importer Warned for Failure to Hold Entry of Cosmetics
The FDA's Atlanta District Office issued a Warning Letter on May 25, 2001, to importer Rigoberto Rimenez, Palmetto, Georgia, for failure to hold an entry of shampoo, deodorant, cough syrup and toothpaste intact at the port of entry pending FDA release of the shipment. FDA notified U.S. Customs to order redelivery of this shipment.
Eye Makeup Remover Contaminated with Pseudomonas - FDA Issues Nationwide Alert
FDA Issues Nationwide Alert Regarding Bacteria in Eye Makeup Remover
On June 8, 2001, the FDA issued a Nationwide Alert warning consumers not to purchase or use Pierre Fabre Physicians Formula Eye Makeup Remover Lotion because it may be contaminated with Pseudomonas fluorescens and/or Pseudomonas putida. This bacteria that can cause severe, sight-threatening infections of the cornea. The manufacturer, Physicians Formula Cosmetics of Azusa, California, a subsidiary of Pierre Fabre, Inc., voluntarily recalled 16,300 bottles of the product.
This product was distributed nationwide through retail stores, pharmacies, and supermarkets from March 14 though May 28, 2001. The product was sold in 2 ounce bottles with #698 on the back of the label and batch numbers #0821 or #0601 imprinted on the bottom of the bottle. The recall was the result of a routine sampling program by the company which revealed that the finished products contained the bacteria.
Ice Cream Recalls
Undeclared Peanuts in Fudge Royale Ice Cream
FDA Conducts Inspection and Obtains Recall Information at Ice Cream Manufacturer
The FDA's Atlanta District Office followed up on a Class 1 Recall at Dairy Fresh, Winston-Salem, North Carolina, regarding Food Lion's brand of Fudge Royale Ice Cream in half-gallon cartons. The product contained undeclared peanuts. The firm had finished production of the Fudge Royale Ice Cream when they changed to Food Lion Tin Roof Ice Cream which contained peanuts. Some of the labels for the Fudge Royale were applied to cartons of Tin Roof Ice Cream. A 24-hour Alert was submitted. The firm issued a Press Release on the recall on August 21, 2001.
This product came in square half-gallon containers of Food Lion Fudge Royale ice cream (UPC 35826-00573), which were marked with a code date of 04 12 02, #1.3783 with the last four numbers 1902 through 2200, found on the end flap closest to the bar code. The company believes only a small portion of the production run contained peanuts.
Undeclared Peanut Butter in Prestige Caramel Coyote Ice Cream
On September 6, 2001, Winn-Dixie Stores, Inc., Jacksonville, Florida, announced a voluntarily recall of one-half gallon packages of Prestige Caramel Coyote Ice Cream with the code date Jan 24 2002. The product was recalled because it might contain undeclared peanut butter. People who have an allergy or severe sensitivity to peanuts run the risk of serious or life threatening allergic reaction if they consume this product.
The product came in one-half gallon containers of Prestige Caramel Coyote Ice Cream which were marked with a three line code date of JAN 24 2002 / ( a four digit time code) / 12-356 found above the UPC Bar Code #21140 27053. The company believed that only a small portion of the production run contained peanut butter. This product was distributed to Winn-Dixie, Thriftway, Jitney Jungle, Save Rite and Sack & Save stores in Alabama, Florida, Georgia, Indiana, Kentucky, Louisiana, Mississippi, North Carolina, Ohio, Oklahoma, South Carolina, Texas, and Virginia. Winn-Dixie removed all of this product from its stores and encouraged all customers who purchased the affected product to return the product to the store where purchased for a full refund or replacement.
Firm Announces Recall of Mint Cookie Ice Cream
FDA Follows-up on Class 1 Recall of Ice Cream with Undeclared Peanuts
On September 7, 2001, Garelick Farms of Massachusetts announced it was voluntarily recalling one-half gallon round containers of Garelick Farms Mint Cookie ice cream. This product may contain peanuts or pieces of peanuts. Individuals with allergies to peanuts run the risk of a serious or life threatening reaction if they consume this product. Garelick Farms initiated the recall after one peanut was discovered in a bag of cookie crunch, which was blended into the mint ice cream.
The ice cream was manufactured by Brigham's Ice Cream Company at its plant located in Arlington, Massachusetts, and was packaged under the Garelick Farms label. The product might have been distributed in stores in Massachusetts, Rhode Island, Connecticut, Maine, New Hampshire, and Vermont. The product came in round half-gallon containers of Garelick Farms Mint Cookie ice cream (UPC 30255-66116), which are marked with a code date of 072402. The company believes 1,000 of the half-gallon containers of the ice cream from the production run were distributed to stores. Delivery truck drivers, distributors, and stores were alerted.
Pistachio Ice Cream Labeled as Chocolate Chip
On June 20, 2001, Friendly Ice Cream Corporation, Wilbraham, Massachusetts, issued a Press Release voluntarily recalled Friendly's Mint Chocolate Chip Ice Cream, Half-Gallon Container. The recalled product had a Code Date embossed in the form of 27Apr02 or Apr2702. The product was recalled the Chocolate Chip ice cream was actually Pistachio Ice Cream containing undeclared pistachios.
The company initiated the recall after learning that pistachio ice cream was packaged in a production run of mint Chocolate Chip ice cream half gallon cartons. A notification was issued to distributors and retail accounts by telephone and fax on June 21, 2001. The FDA's New England District Office conducted an inspection at the firm on June 21, 2001, and obtained recall information.
FDA Assists Firm in Recall of Cheese
Recall Initiated Following Outbreak of Salmonella Associated with Cheese
On May 4, 2001, Caserficio Moderno, Inc., d.b.a. Liuzzi Cheese Co., North Haven, Connecticut, issued a press release regarding a recall of fresh mozzarella, whole milk ricotta and basket cheese. The recall was initiated as a follow-up to an outbreak of Salmonella Newport in Connecticut and Massachusetts. The firm, working with New England District Recall Coordinator, put out a press release via the Associated Press on May 4. The firm also sent a recall letter to all 93 wholesale, retail and restaurants in Connecticut, Massachusetts, New York, New Jersey, and Rhode Island.
FDA conducted an inspection of Caserficio Moderno Inc. d.b.a. Liuzzi Cheese Co., North Haven, on May 4 - 9, 2001. Implicated products were mozzarella, basket and ricotta cheeses manufactured before Easter. The State of Connecticut Dept. of Agriculture asked the firm to stop manufacture and distribution of all cheeses on May 2. The inspection revealed the firm was voluntarily recalling all known expiration dates and packaging types of fresh mozzarella, whole milk ricotta and basket cheese. Voluntary destruction of all products recovered to date was witnessed.
Undeclared Whey in Unsalted Stick Margarine
Allergic Reactions Reported to Unsalted Stick Margarine
On September 20, 2001, ConAgra Dairy Foods of Downers Grove, Illinois, voluntarily recalled less than 3,000 pounds of Fleischmann's Unsalted Stick Margarine. The recall was initiated because the product might contain an undeclared dairy ingredient. People who have an allergy or severe sensitivity to dairy products may run the risk of serious or life threatening allergic reaction if they consume this product.
Affected product was distributed through retail stores in the following states: Maryland, Mississippi, Vermont, Michigan, Virginia, Pennsylvania, Maine, Alabama, Massachusetts, New Hampshire, Ohio, Kentucky, New Jersey, Connecticut, Tennessee, Rhode Island, New York, Georgia, West Virginia.
This Fleischmann's Unsalted Stick Margarine could be identified with the "best if used by" date on the carton of JAN 31 02 ON. Two allergic reactions were reported. Other than to dairy sensitive consumers or to consumers on a sodium free diet, the product being recalled is safe for consumption.
The product could actually have been Fleischmann's Original Stick Margarine containing whey, a dairy protein. The product can be easily identified by the inner wrap on the individual sticks that reads, "Fleischmann's Original Margarine," instead of Unsalted. This product was recalled in cooperation with the FDA.
Soapy Cheese Destroyed
The FDA's Philadelphia District Office reported that on September 7, 2001, the Wal-Mart Distribution Center in Bedford, Pennsylvania, voluntarily destroyed 3,292 cases of assorted cheeses. The cheese was valued at $65,708. The cheese had an odor that smelled like soap after being shipped in a trailer that had previously been used to ship cleaning compounds and disinfectants. The cheese was manufactured for Wal-Mart and packaged under their "Great Value" brand name.
Moldy Cheese Destroyed
Improper Packaging Causes Moldy Cheese
The FDA's Philadelphia District Office reported that on May 14, 2001, a defect in the vacuum packaging at Laubscher Cheese Company, Mercer, Pennsylvania, resulted in the improper packaging of 10,610 pounds of shredded Swiss and Cheddar cheese. The firm initiated a recall of the cheese after it began to exhibit mold growth. The firm's initial action was to divert the cheese to animal feed. After discussions with the FDA's Center for Veterinary Medicine and the Philadelphia District Officials, the firm decided to voluntarily destroy the cheese. On June 26, 2001, the cheese was loaded onto a contract waste disposal truck and subsequently destroyed.
Warning Letter Issued for Failure to Recall
Firm Warned for Selling Contaminated Nutritional Supplements
On August 2, 2001, the FDA's San Juan District Office sent a Warning Letter to the Owner and President of Necco, Inc., doing business as Freshmart, in Carolina, Puerto Rico. On May 25, 2001, the FDA conducted a Class I recall audit check inspection of the firm's health store in Carolina, Puerto Rico. The inspection revealed that the firm had continued to sell a recalled nutritional supplement, Nature's Plus Ultra-Zyme, Hypo-Allergenic 90 Tablets. The product was subject to recall because it was contaminated with Salmonella.
The Warning Letter advised that this violation may result in FDA taking regulatory action, including but not limited to, seizing adulterated foods and obtaining a court injunction. The letter also advised the president of Necco, Inc., that FDA had advised the Secretary of Health for the Commonwealth of Puerto Rico of FDA's findings of the recall audit check and that FDA had recommended that the Department of Health evaluate these findings and take any further action they deem necessary.
Warning for Supplements Promoted for Cure of Diseases
The FDA's Seattle District Office issued a Warning Letter to Barlean's Organic Oils, LLC, Ferndale, Washington for violations of 21 C.F.R. 505, 502 and 403 of the Act. The firm's products - Forti-Flax, Flax Oil, Flax Oil Capsules, Omega Twin, The Essential Woman, Borage Oil, and other products made claims that these products were useful in the treatment of various diseases. These diseases included AIDS, various cancers, Alzheimer's, cystic fibrosis, diabetes, heart disease, kidney disease, leukemia, lupus, multiple sclerosis, schizophrenia, and stroke. All of the products are marketed as dietary supplements or foods, however, the labeling included statements that represented or suggested that these products are intended to be used in the cure, mitigation, treatment or prevention of disease.
Dietary Supplements Containing Tiratricol
FDA Warns Consumers Against Consuming Tiratricol
Potent Thyroid Hormone Promoted as Dietary Supplement
On November 21, 2000, the FDA warned consumers of products marketed as dietary supplements that contained tiratricol, also known as triodothyroacetic acid or TRIAC. The product is a potent thyroid hormone that may cause serious health consequences including heart attacks and strokes. Despite four recalls over seven months, various products that contained tiratricol continued to reach consumers. FDA urged all consumers to stop using such products immediately.
Previously, on November 11, 1999, FDA warned the public against consuming Triax Metabolic Accelerator, a dietary supplement for weight loss by Syntrax Innovations, Inc., Cape Giradeau, Missouri. Since this action, several other firms have recalled similar products containing tiratricol. Distribution of these products has been primarily through retail sales to health food stores, fitness centers, and gymnasiums.
FDA urged all individuals who may have purchased these products, or any product containing tiratricol, to stop using them immediately and, in addition, to consult their health care professional if they experienced any adverse effects, which may include insomnia, nervousness, sweating, and diarrhea.
Firm Recalls Dietary Supplement Containing Tiratricol
The FDAÂ’s Philadelphia District Office reported that on July 27, 2001, ATF Fitness Products, Inc., Oakmont, Pennsylvania, issued a press release for BioPharm brand T- Cuts, a dietary supplement. The press release stated that the product was being recalled because it contained Tiratricol, also known as triodothyroacetic acid or TRIAC, a potent thyroid hormone that may cause serious health consequences including heart attacks and strokes. All lot numbers were involved in the recall. The product was sold nationwide at retail stores and via mail order.
Firms Recalls Own Brand of Tiratricol
On September 5, 2001, Global Enterprises, College Station, Texas, issued a Press Release stating that the firm was recalling its own label brand of Tiratricol, sold under the name "T3." The product was contract manufactured for Global Enterprises by Gold Desert Manufacturing of Phoenix, Arizona. A total of 8,253 bottles of 90 capsules were sold between approximately May 24, 2001, and August 6, 2001.
Injunction Order for Syntrax Innovations, Inc.
Court Enjoins Firm From Marketing Dietary Supplement Containing Tiratricol
United States v. Syntrax Innovations, Inc., et al., (E.D. Mo.). On February 14, 2001, Judge Rodney Sippel entered an order of injunction against Syntrax Innovations, Inc. This case involves a drug called Triax, manufactured by Syntrax as a dietary supplement to promote weight loss. FDA alleged that Triax (which consists of tiratricol, a thyroid hormone) could not be a dietary supplement because it was promoted to treat a disease (obesity) and because it did not contain any of the dietary ingredients identified in the definition set forth in DSHEA.
The case began as a seizure, but the government amended the complaint to request injunctive relief. A preliminary injunction had been in effect since March 3, 2000, to prevent the distribution of Triax. Defendants originally contested the case, but later conceded that Triax is a drug based on the government's disclosure that there is an IND in effect for tiratricol. Under DSHEA, the term dietary supplement does not include an article authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public.
Notwithstanding defendants' admission of liability, defendants and the government could not agree on a consent decree. Defendants argued to the court that the relief sought by FDA was "overreaching, oppressive, and punitive," and asked the court to enter an order devoid of many of the provisions FDA usually seeks in an injunction. Specifically, defendants objected to provisions that would: grant FDA inspection authority apart from the authority conferred by 21 U.S.C. § 374; require defendants to pay for inspections; enjoin defendants from distributing any unapproved new drugs and any misbranded drugs (besides the specific product at issue in this case); enjoin defendants from distributing any product with "Triax" in its name; require defendants to notify all Triax purchasers that distribution of Triax is prohibited; require defendants to serve a copy of the order upon each of their agents, employees, and all people in active concert or participation with defendants; require defendants to conduct a recall if FDA deems it warranted; and require defendants to cease manufacturing and distributing any article upon a letter from FDA stating that defendants are in violation of the injunction.
On February 14, 2001, Judge Rodney Sippel entered an order of injunction that included every provision requested by FDA except for one (which sought reimbursement of travel expenses incurred by government attorneys, for a deposition.) The accompanying opinion by Judge Sippel noted that the terms proposed by the government have been routinely ordered in other cases. Specifically, the judge found that contrary to defendants' arguments, the injunction proposed by the government "describes with particularity the type of conduct sought to be restrained and does not simply require defendants to 'follow the law.'"
In barring the sale by defendants of any product containing the word "Triax" in its labeling, the court noted that defendants have been marketing a product called "Triax II," and that defendants should not "be permitted to continue profiting, either directly or indirectly, from the sale of an illegal drug."
The court agreed with defendants that the inspection authority requested by the government exceeds the scope of § 374, but said that "does not compel the conclusion that the inspection authority proposed by the government is unreasonable or unnecessary. The inspection authority needed by the FDA to ensure that defendants are complying with the terms of [this] order should be more extensive than the statutory authority granted the FDA to determine whether the FDCA is, in fact, being violated." Finally, the court found that the recall and letter shutdown provisions requested by FDA are necessary, and that such relief is routinely ordered by other courts to ensure compliance with the terms of an injunction.
On March 2, 2001, an investigator from the Denver District Office assisted a Deputy U.S. Marshal with the destruction of 32 Kg. of Tiratricol and approximately 4,000 TRIAX labels. The destruction was in response to the Order issued by U.S. District Judge Rodney W. Sippel, in the case of U.S. v. Syntrax Innovations, Inc. The product and labeling were originally seized at the contract manufacturer, Pharmatech Labs, Inc., Lindon, Utah, on December 13, 1999.