Qualitest Recalls Hydrocodone Bitartrate/APAP Tablets

[UPDATE 12/21/12:  Mylan announced a voluntary recall of three lots of Hydrocodone Bitartrate and Acetaminophen 10mg/500mg Tablets. The affected lot numbers are #30378411, #3040859, and #3042573. These were manufactured by Qualitest, and repackaged and distributed by Mylan in unit dose (CD100) under the UDL Laboratories label.]

Qualitest has issued a nationwide voluntary recall for 101 lots of Hydrocodone Bitartrate and Acetaminophen 10mg/500mg Tablets due to potentially oversized tablets. Qualitest commenced the recall as a precautionary measure due to the possibility that tablets from affected lots exceed the weight specification and contain potent doses of the ingredients hydrocodone bitartrate and acetaminophen.

The affected lot numbers include the following NDC numbers, and lot numbers beginning with the letter “C”:

NDC #	Bottle Count Related Content
0603-3888-16	30
0603-3888-20	60
0603-3888-02	90
0603-3888-21	100
0603-3888-22	120
0603-3888-26	150
0603-3888-04	180
0603-3888-28	500
0603-3888-32	1000

Unintentional administration of increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume >3 alcoholic beverages per day. Moreover, 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 elderly patients, severe kidney or liver impairment, or those that are taking certain sedatives and antidepressants.

Hydrocodone Bitartrate and Acetaminophen 10mg/500mg Tablets are indicated for the relief of moderate to moderately severe pain.

For more information call (800) 444-4011 or visit www.qualitestrx.com.