FDA Voluntary Hydrocodone Product Recall - From myMatrixx

FDA Voluntary Product Recall - From myMatrixx

Hydrocodone - APAP 10mg/500mg

Dear myMatrixx Clients,

On December 20, 2012 a voluntary recall was issued for hydrocodone bitartrate and acetaminophen tablets 10 mg/ 500mg. This recall follows a recall issued on both September 10, 2012 and December 6, 2012 for the same product. 

myMatrixx is informing our payers of this recall in the case that injured patient taking this medication call with concerns. There is no need for payers to take any additional action related to this recall at this time. Additional information can be found at http://www.fda.gov/Safety/Recalls/default.htm.

The affected bottles of medication were recalled due to the possibility that some tablets might be oversized and contain more acetaminophen than they should. If patients consume too much acetaminophen they could be at risk for liver damage.  Patients who take other acetaminophen containing products, those who have liver problems, or patients who consume more than 3 alcoholic beverages per day are at increased risk for liver toxicity.

Additionally, myMatrixx Mail Service pharmacy has never stocked any of the recalled products so no patients on our mail service program have been affected. In addition, the retail pharmacies in our network have all been informed how to advise patients that may have received any of the recalled lots.

How should claims professionals respond if an injured worker calls? 

Direct patients with questions or concerns to contact their local pharmacy or healthcare provider.

Patients with affected product distributed by Qualitest should contact 1-800-444-4011.

Patients with affected product distributed by Mylan should contact 1-800-848-0462.

Further action? 

MyMatrixx will continue to monitor any FDA alerts regarding this issue medication and other medication related alerts.  Notification will be provided as pertinent information becomes available or if further action is required.

References

FDA Recalls, Market Withdrawals, and Safety Alerts. Qualitest Issues a Voluntary, Nationwide Recall for One Lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg/500mg Due to the Potential for Oversized Tablets. Available at: http://www.fda.gov/Safety/Recalls/ucm318827.htm. Accessed December 26, 2012.

FDA Recalls, Market Withdrawals, and Safety Alerts. Qualitest Issues Voluntary, Nationwide Recall of 101 Lots of Hydrocodone Bitartrate and Acetaminophen Tablets, Usp 10mg/500mg Due to the Potential for Oversized Tablets. Available at: http://www.fda.gov/Safety/Recalls/ucm331218.htm. Accessed December 26, 2012.

FDA Recalls, Market Withdrawals, and Safety Alerts. Voluntary Product Recall Initiated by Qualitest Pharmaceuticals Impacts Three Lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg/500mg Repackaged and Distributed by Mylan Institutional. Available at: http://www.fda.gov/Safety/Recalls/ucm333153.htm. Accessed December 26, 2012.

Sincerely,

Phil Walls, RPh

Chief Clinical and Compliance Officer, myMatrixx