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Center for Drug Evaluation and Research cont. 2001

Chapter 3

Last Update: August 07, 2003

Bioresearch Monitoring Program


Warning Letter Issued to Repacker of APIs
Failure to Have Written Procedures for Significant Aspects of Operation Results in Warning Letter

The FDA's New Orleans District Office Nashville Branch issued a Warning Letter on July 2, 2001, to Meridian Pharmaceuticals, Inc., Decatur, Alabama. The firm is a repacker of active pharmaceutical ingredients. The letter was based on an FDA inspection of the firm on February 21-22, 2001, and March 5-7, 2001. The inspection revealed a number of CGMP deviations including the following: failure to assign expiration dating to numerous API products; failure to demonstrate adequacy of some expiration dates that were assigned; failure to have drug product container-closure and master label specifications for each product that the firm repackaged; and failure to have written procedures (SOPs) for some significant aspects of their operations.

Drug Repacker Ceases Operations

On February 2, 2001, the FDA's New Orleans District Office conducted a follow-up inspection of PharmaScience Laboratories, Inc., Madison, Mississippi. The inspection was conducted as a follow-up to a previous violative inspection. The firm, a prescription and over-the-counter drug repackager, notified the District that it had voluntarily ceased its drug operations and relinquished its drug registration.

Prescription Drug Distribution Facility

Warning Issued for Improper Storage Conditions
FDA Inspection Discloses Improperly Stored Drugs Returned to Market

On September 6, 2001, the New England District issued a Warning Letter to Bindley Western Industries, Dublin, Ohio. FDA issued the letter following an inspection of the firm's wholesale prescription drug distribution facility in Westbrook Maine, on January 30 and February 16, 2001. The Warning Letter cited the firm for failure to exercise proper control (during storage, delivery, and re-delivery) of temperature sensitive drugs and vaccines.

Other deviations noted in the Warning Letter included: returning to the marketplace drug products that had been subjected to improper storage conditions; failure to assure that all prescription drugs were stored at appropriate temperatures and under appropriate conditions; failure to consider the conditions under which a drug was held, stored, or shipped before or during its return; and failure to establish, maintain, and adhere to certain written policies and procedures.

Internet Enforcement Activities

CDER Issues Cyber Letters
FDA Issues Cyber Letters to Websites for Selling Rx Drugs Without a Valid Prescription

In December 2000, the FDA's Center for Drug Evaluation and Research began issuing Cyber Letters. These letters were sent electronically via the Internet to Websites that were offering to sell prescription drugs to U.S. citizens without valid (or in some cases without any) prescription. CDER also issued Cyber letters to firms for promoting various products on-line with therapeutic claims that cause the products to be drugs. These products were not generally recognized as safe and effective for their intended use and did not have prior approval from FDA to promote the product. Since December 2000, CDER has issued over 100 Cyber letters.

Many prescription drugs available from foreign sources are either products for which there is no U.S. approved counterpart or foreign versions of FDA-approved drugs. In either case, these products are not approved for use in the U.S. and therefore, it is illegal for a foreign source to ship these products into the U.S. The Cyber letters provided these foreign operators with an explanation of the statutory provisions that govern interstate commerce of drugs in the United States, as well as a warning that future shipments of their products to this country may be automatically detained and subject to refusal of entry. Hard copies of each Cyber letter are sent to the Website operator, the U.S. Customs Service and to regulatory officials in the country in which the operator is based.

These Cyber letters are available on FDA's Website at http://www.fda.gov/cder/warn/cyber. Matters described in all FDA Warning Letters are subject to subsequent interaction between FDA and the recipient of the letter and may have changed the regulatory status of the issues discussed in the letter.

Christian Brothers Contracting Corp. Signs Consent Decree
Firm Signs Consent Decree and Agrees to Stop Manufacturing, Processing, and Distributing Laetrile

On November 16, 2000, Christian Brothers Contracting Corporation and its President, Jason Vale, signed a consent decree of permanent injunction in which it agreed to stop manufacturing, processing, and distributing its amygdalin products, also referred to as Laetrile, Vitamin B-17 or apricot kernels. The products were promoted for use in cancer therapy. The consent decree was entered by United States District Court Judge John Gleeson in Brooklyn, New York. Amygdalin is a glucoside found in the kernel or seeds of most fruits and is frequently referred to as "Laetrile" or "Vitamin B-17." While some proponents have recommended it for the treatment and control of cancer, these claims have never been approved by the FDA. There are no published clinical studies which demonstrate that Laetrile is safe and effective and cancer patients who take it sometimes forgo conventional therapies to their detriment.

The government's action in this case follows prior inspections of defendants' facilities in New York and several undercover purchases from defendants which revealed that the amygdalin or Laetrile products were being promoted as a drug for the cure, mitigation, treatment and prevention of cancer. The government also alleged that defendants used Internet web sites to sell and market its amygdalin products. Despite warnings from FDA, Christian Brothers continued to distribute its laetrile products into interstate commerce.

The court had preliminarily enjoined the defendants from selling amygdalin on April 20, 2000. The consent decree signed by Christian Brothers and its president will ensure that defendants keep their commitment with the agency to permanently discontinue selling amygdalin products.

Over-the-Counter Drugs

Eye and Nasal Drops Found Contaminated
Ophthalmic Drug Product Manufactured in Unsterile Conditions

The FDA's Los Angeles District Office Drug Group investigator initiated an inspection of All Thats Natural II, Inc., on June 6, 2001. The firm distributes MSM Eye and Nasal Drops. The product was found to be adulterated in that the active ingredient (methylsulfonylmethane) is not permitted in ophthalmic drug products. Furthermore, the product was not manufactured under sterile conditions. Samples obtained by the FDA's Los Angeles District Office were positive for gram negative anaerobic rods identified as Klebsiella Pneumonia as well as gram negative aerobic rods identified as Pseudomonas Mendocina.

The firm initiated a recall of all distributed product and promised to cease further distribution. The manufacturer of the product, Allure Cosmetic, Inc., Hayward, California, stated they would no longer manufacture MSM Eye and Nasal Drops.

Drug for Motion Sickness Recalled

The FDA's New York District Office received notice on September 4, 2001, from the Director of Quality Assurance from PL Developments in Farmingdale, New York. The firm official contacted the FDA to alert the district of low dissolution results obtained from a private laboratory. The firm initiated a recall by letter on September 7, 2001.

Bottles of Hydrozyme and HCL-Plus were distributed nationwide from February 19th to April 25th, 2001. The product came in white bottles with blue labels. The Hydrozyme lot numbers recalled were 1173, 21245 and 21280. The HCL-Plus lot number being recalled was 21150.

Recall of Benadryl Allergy and Sinus Fastmelt Tablets
Product Labeled as Containing Phenylalanine at 1.2 mg Per Tablet Actually Contained 4.6 mg Per Tablet

The FDA's New Jersey District Office was alerted of a recall of Benadryl Allergy and Sinus Fastmelt Tablets. The firm, Warner Lambert Consumer Group, Pfizer, Inc., Morris Plains, New Jersey, alerted the district about a recall of their Benadryl Allergy & Sinus FASTMELT tablets, all lots, due to the labeling incorrectly listing the amount of Phenylalanine as 1.2 mg per tablet when the product actually contains 4.6 mg per tablet. Phenylalanine is contained in the artificial sweetener aspartame, which is an inactive ingredient in the product. The labeling error did not affect the general public, however, the labeling error may be of concern for the population having a rare inherited metabolic condition known as Phenylketonuria (PKU). The firm is recalling to the consumer/user level. A press release was sent out on June 1, 2001. The district monitored the recall to completion.

Perrigo Co. Recalls Children's Pain Reliever
Lot Found to Contain 29 Percent More Acetaminophen Than Labeled Amount

On August 15, 2001, the Perrigo Company of Allegan, Michigan, announced that, in cooperation with the FDA, it was conducting a recall of 7,788 four-ounce bottles of cherry-flavored pain reliever suspension liquid with Lot Number 1AD0228. Perrigo determined that this lot might contain an excess of up to 29 percent over the labeled amount of acetaminophen. The product was recalled because overdoses of acetaminophen can lead to severe health problems including liver toxicity and liver failure.

The product, which is used to treat headaches and fevers in children, was sold under the Good Sense® label at various small independent retail chains across the country, under the Hy-Vee® label at Hy-Vee stores in Illinois, Iowa, Kansas, Minnesota, Missouri, Nebraska and South Dakota and under the Kroger® label at Kroger stores in Alabama, Arkansas, Georgia, Illinois, Indiana, Kentucky, Louisiana, Michigan, Mississippi, Missouri, North Carolina, Ohio, South Carolina, Tennessee, Texas, Virginia and West Virginia. Perrigo immediately notified the FDA as well as the retailers and wholesale distributors of this product. Of the 7,788 bottles affected in this recall, Perrigo estimated that approximately 6,500 were purchased by consumers. The rest were removed from retailersÂ’ shelves and inventory.

Seizure of Corticosteroid Drugs Sold OTC
OTC Creams With Prescription Corticosteroids Seized

On January 17, 2001, FDA investigators assisted the U.S. Marshals Office in seizures of corticosteroid drug products at six different locations in the State of Florida The products were various skin creams containing prescription corticosteroid drugs with ingredients such as clobetasol, betamethasone, or fluocinonide. The products were being sold OTC at local retail stores. The six locations of the seizures were as follows:

Cloverleaf Market and Beauty Supply, Miami, Florida;
C&L Trading of Miami, Miami, Florida;
Beauty Supermarket, North Miami Beach, Florida;
Ariang Beauty Collection, Fort Lauderdale, Florida;
A&B Florida Distributors, Miami, Florida; and
Nu Look Beauty Supply, Miami, Florida.

These products were originally placed under a State of Florida "stop sale" as part of "Operation Skin Cream Blitz" on October 19, 2000. On August 2, 2001, the FDA's Florida District Office witnessed the destruction of these products. The estimated value of the products was $24,584.00.

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