According to the latest news from federal agency United States Food & Drug Administration, Qualitest, a subsidiary of Endo Health Solutions is issuing a voluntary and nationwide recall for 101 lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg due to over size. According to the company and the report from FDA, bottles from the affected lots may contain tablets that have a higher dosage of acetaminophen, and as a result, it is possible that consumers could take more than the intended dose and hence it is important to stop consumers from doing so.

A higher dose of Acetaminophen and Hydrocodone Bitartrate than the prescribed one could put human health in jeopardy and is linked with a plenty of side effects including liver impairment, kidney disorders, sedation and respiratory depressions. A higher dose of the drug readily interacts with other medications like antidepressants and creates health hazards. Unintentional administration of tablets with increased dose of acetaminophen could cause liver toxicity, particularly in patients with compromised liver function and who are under other acetaminophen containing medications.

The company has asked medical professionals and pharmacists to check their inventories for the affected lots, separate the affected material from the lots to contact MedTurn at 1-800-967-5952 for instructions on product return. The company has also asked the pharmacists and health care facilities post a copy of the press release in their pharmacy area so that the message could be spread.

Patients, Pharmacists, Healthcare professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at FDA Adverse Event Reporting Page.

Products with the following NDC numbers and lot numbers beginning with the letter ā€œCā€ are potentially affected and pharmacists are requested to take care of those. The details of the product are as mentioned below:

IDC Number Bottle count
0603-3888-16 30
0603-3888-02 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

It is important to underline here that the company had also initiated a voluntary recall of the same product earlier also but for a different lot. The product that was recalled at that time was Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. The lot number for the recalled tablets was C1440512A, having the NDC 0603-38888-21,100 and expiry was recorded for 12/13.

Acetaminophen 10 mg/500 mg and Hydrocodone are generally prescribed for those patients who are suffering from moderate to severe pain. The defective lot of Acetaminophen tablet was sold and distributed between Feb. 20, 2012 and Nov. 19, 2012 to wholesale distributors and retail pharmacies nationwide.