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Health Highlights: May 17, 2008
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The findings were published in the May/June issue of the journalChild Development.
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Scientific Laboratories Inc. Banned From Making, Distributing Drugs
Scientific Laboratories Inc. has been banned from making and distributing drug products until their manufacturing operations meet federal regulations and their products are approved, the U.S. Food and Drug Administration said Friday.
The company is a contract manufacturer and distributor of various prescription cough and cold products. A number of Scientific Laboratories' drugs "have not undergone FDA review for safety and efficacy and may pose potential health risks," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a prepared statement.
The unapproved new drugs manufactured and marketed by Scientific Laboratories as prescription cough and cold products include: B-Vex Suspension; Ben-Tann Suspension; D-Tann Suspension; D-Tann AT Suspension; D-Tann CT Suspension; D-Tann DM Suspension; D-Tann HC Suspension; Dur-Tann DM Suspension; Duratan DM Suspension; L-All 12 Suspension; Nazarin Liquid; and Nazarin HC Liquid.
Pharmacies should stop dispensing these products, and consumers with these products in their homes should talk to their health care provider about whether to stop using the products, the FDA said.
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Texas Seafood Producer Ordered to Close, Recall Products
A seafood processing company in Texas has been ordered to close down and recall all products manufactured at its facility since 2007, the U.S. Food and Drug Administration said Friday.
Under a different name, Hope Food Supply Inc., of Pasadena, Texas, had made dried smoked catfish steaks and other smoked seafood products but was ordered to close until it developed and implemented an adequate Hazard Analysis and Critical Control Point (HACCP) plan for its products.
The company hasn't developed this plan and can't resume production until it's implemented an approved HACCP plan, the FDA said. This type of plan requires the company to identify all food safety hazards likely to occur with each type of seafood product they process and establish preventive measures to control those hazards.
Without such a plan, seafood products could contain potentially harmful bacteria that could cause serious illnesses in people.
Hope Food Supply's products have been distributed across the United States. Consumers should take any smoked seafood products to the place of purchase to determine if the products came from Hope Food Supply. If so, the products should be thrown away, the FDA said.
Consumers who have eaten Hope Food Supply dried smoked catfish or other smoked seafood products and have suffered adverse reactions should consult a health care professional.
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