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This article was originally published in The Tan Sheet

Executive Summary

WARNER-LAMBERT CLASS II RECALL OF FRAGRANCE-FREE LUBRIDERM LOTION was essentially completed in January and the company is currently awaiting word from FDA officially to end the recall. The recall of 61,384 bottles of Lubriderm lotion for dry skin from lot number 911N1Va was due to pseudomonas aeruginosa contamination that occurred at the company's Vega Baja, Puerto Rico manufacturing plant. Warner-Lambert announced the Class II recall in a Sept. 1 letter to wholesalers. (See following chart for other OTC/nutritional product recalls in FDA's March 31 "Enforcement Report.") The contamination was discovered through routine quality assurance testing conducted during the production process, Warner- Lambert commented. The agency has reported a series of quality assurance problems from 1992, affecting prescription products as well as the Lubriderm recall. The Puerto Rico quality assurance unit has "been revamped from top to bottom," the company reported in late November. "New management of the quality functions is in place and a major reorganization is underway to improve quality support operations," W-L told FDA after a late 1992 inspection at the plant. Warner-Lambert said the bacteria was present in the water that was used in the production of the product. Following the incident, the firm has improved its water purification system and instituted more frequent product testing for bacterial contamination. The company said it did not receive any reports of problems associated with the products from consumers.

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