Safety Alerts & Recalls

What does this mean?

Hydrocodone bitartrate and acetaminophen 10 mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain. Hydrocodone bitartrate and acetaminophen tablets are available under the generic name and brand names such as Co-Gesic, Lortab, and Vicodin. This medicine is available in a variety of strengths and from many different manufacturers.

The affected lot, C1440512A, is made by Qualitest. The lot number can be found on the side of the manufacturer’s bottle. Hydrocodone Bitartrate and Acetaminophen Tablets from Qualitest are pink, capsule-shaped tablets, with "3600" on one side of the tablet and "V" on the other.

If you think your prescription for Hydrocodone Bitartrate and Acetaminophen Tablets, 10 mg/500 mg is made by Qualitest and is from the recalled lot C1440512A, you should contact Qualitest at 1-800-444-4011; Monday through Friday between the hours of 8 a.m. and 5 p.m. CST. If you are unsure if you have the affected lot number, you should consult your pharmacy or health care provider.

Healthcare providers and patients are encouraged to report side effects related to the use of their medicines to the FDA's MedWatch Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Qualitest Recalls One Lot of Hydrocodone Bitartrate and Acetaminophen Tablets

The manufacturer Qualitest has issued a voluntary, nationwide retail level recall for the following: Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg, NDC 0603-3888-21, 100 count, Lot Number C1440512A, expiry date 12/13.

It is possible that some tablets from this lot may be oversized and may contain a higher dosage of the ingredients Hydrocodone Bitartrate and Acetaminophen. Taking a higher dosage of acetaminophen than intended could potentially cause severe liver damage, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Taking a higher dose of hydrocodone than intended could result in an increase in the severity or frequency of side effects, such as sedation or respiratory depression, particularly in patients who are elderly, have severe kidney or liver impairment, or are also taking interacting medications, for example other sedating medications or certain antidepressants.

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Source: Manufacturer
Publication Date: 2012-09-12
Last Updated: 2012-09-12

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