Oversized Pills Recall Issued by Qualitest

The Food and Drug Administration (FDA) announced that Qualitest, a subsidiary of Endo Health Solutions, issued a nationwide recall for one lot of Hydrocodone Bitartrate and acetaminophen tablets over concerns the pills may exceed the weight specifications and thus be highly potent.

These tablets are prescribed for moderate to moderately severe pain. The specifications for the recalled products are:

• Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg, NDC 0603-3888-21, 100 count, Lot Number C1440512A, expiry date 12/13

The FDA warned that the increased acetaminophen content from the oversized drugs may cause liver toxicity, especially in patients on other acetaminophen medications, patients with liver dysfunction, or people who consume more than three alcoholic beverages per day.

Increased hydrocodone content may result in an increased severity of side effects, such as sedation or respiratory depression, especially in elderly patients, those with severe kidney or liver impairment, and those on interacting medications like sedatives and antidepressants.

No injuries have been reported to date. Those consumers who have drugs from the affected lot have been asked to contact Qualitest. If the consumers are not sure about the lot number, they should seek advice from their health care professional or the pharmacy.

If you or a loved one has been harmed by a dangerous drug, contact Sokolove Law for a free legal consultation and to find out if a dangerous drug lawyer may be able to help you.

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