Under What Circumstances Are Drugs Recalled?
On Apr. 30, 2010, Johnson & Johnson's McNeil Consumer Healthcare division issued a recall of certain liquid medications for children and infants, including popular over-the-counter drugs like Children's Tylenol (acetaminophen) and Children's Motrin (ibuprofen). This recall by McNeil is in cooperation with the U.S. Food and Drug Administration (FDA).
In this case, the recall was due to findings of thick dust and grime on certain equipment, a hole in the ceiling, duct-tape-covered pipes, raw ingredients contaminated with bacteria, and a lack of quality-control procedures at a Johnson & Johnson manufacturing facility in Fort Washington, Pa. Forty products were affected by the recall.
Although the FDA admitted that the chances of becoming sick from these products were "remote," they still encouraged caution and advised consumers to use generic or alternative versions of these medications.
What Are the Steps in a Drug Recall?
When a product recall is issued, stores pull the products from shelves to ensure that no further sales of the recalled product can occur. Whenever there is a drug recall, you can also determine whether you have purchased affected medications by checking the product's NDC number on the package (National Drug Code number, a unique identifying number for medications intended for human use). The NDC number is a 10-digit number containing three segments that denote the drug's vendor, the specific product, and the type of packaging.
For the 2010 J&J recall, affected NDC numbers can be found on the FDA web site (http://www.fda.gov/) as well as on the web site for McNeil Consumer Healthcare (http://www.mcneilproductrecall.com/). Refunds for purchased product and/or coupons for replacement of recalled drugs are also available from the manufacturer's web site.
If you have purchased medication affected by a recall, dispose of it properly and do not use the medication. Confirm that your product carries an NDC number affected by the recall by checking on the web site for the company or the FDA web site. Your pharmacist can help you choose generic or alternative versions of the recalled medications. If you would like to purchase new versions of the affected products, you can ask your pharmacist to verify that the product contains an approved NDC code.
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United States. U.S. Food and Drug Administration. "McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants' and Children's Products." May 3, 2010. <http://www.fda.gov/safety/recalls/ucm210443.htm>.