FDA Finds Dust And Contaminated Ingredients at Johnson & Johnson Plant, Where Recalled Childrens Medications Were Made.

 "Consumers should not use these products," Deborah Autor, director of the Office of Compliance at FDA's Center for Drug Evaluation and Research told reporters in a conference call, even though the chance of getting sick from the recalled products (Johnson And Johnson Recalls Infant Tylenol, Mocrin And Zyrtec Medications) was "remote."A Food and Drug Administration report released on Tuesday said its inspectors found thick dust and grime covering certain equipment, a hole in the ceiling and duct tape-covered pipes at the Fort Washington, Pennsylvania, facility that made 40 products recalled last Friday.
Inspectors also found raw ingredients contaminated by an unspecified bacteria, a lack of quality control procedures and poor handling of complaints, according to the report dated April 30.
The findings were a further blow to J&J's reputation, as the FDA later on Tuesday urged parents to choose private label alternatives for the over-the-counter medications and said it was weighing possible further regulatory action.

Via Reuters.

Johnson And Johnson Recalls Infant Tylenol, Mocrin And Zyrtec Medications

Johnson And Johnson Recall, Infant Tylenol Recall, Mocrin Recall, Zyrtec Recall,

Even though we posted this recall of Infant Tylenol, Mocrin And Zyrtec Medications five days ago, we would like to repost the matter as it is related to infant health in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.

Please read carefully and follow the instructions to safeguard yourselves. Click here to request a refund or high value coupon.

Johnson & Johnson's McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait. (SEE RECALLED PRODUCT LIST BELOW).

McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.

The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.

Consumers can contact the company at 1-888-222-6036 and also atwww.mcneilproductrecall.com. Parents and caregivers who are not sure about alternative pediatric health treatment options should talk to their doctor or pharmacist and are reminded to never give drug products to infants and children that are not intended for those age groups as this could result in serious harm.

For additional information, including affected NDC numbers, consumers should visit our website www.mcneilproductrecall.com or call 1-888-222-6036 (Monday-Friday 8 a.m. to 10 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time). Any adverse reactions may also be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

McNeil Consumer Healthcare, Division of McNeil-PPC, Inc. markets a broad range of well-known OTC products.

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CLICK HERE FOR RECALL INFORMATION ON CERTAIN INFANTS' TYLENOL® AND CHILDREN'S TYLENOL® PRODUCTS

CLICK HERE FOR RECALL INFORMATION ON CERTAIN INFANTS' MOTRIN® AND CHILDREN'S MOTRIN® PRODUCTS

CLICK HERE FOR RECALL INFORMATION ON CERTAIN CHILDREN'S ZYRTEC® PRODUCTS

CLICK HERE FOR RECALL INFORMATION ON CERTAIN CHILDREN'S BENADRYL® PRODUCTS

CLICK HERE FOR INFORMATION ON ALL RECALLED PRODUCTS FROM APRIL 30, 2010