Mylan Recalls Painkiller Pills due to Risk of Higher Dosage - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Mylan Recalls Painkiller Pills due to Risk of Higher Dosage


ePT--the Electronic Newsletter of Pharmaceutical Technology

Mylan issued on Dec. 20, 2012, a voluntary recall of three lots of the painkiller tablets, hydrocodone bitartrate and acetaminophen, USP 10 mg/500 mg, due to the potential risk that these lots (lots 3037841, 3040859 and 3042573) may exceed the potency stated on the label. The hydrocodone bitartrate and acetaminophen tablets were manufactured by Qualitest Pharmaceuticals, a subsidiary of Endo Health Solutions. Mylan repackaged and distributed the product under the UDL Laboratories Inc. label.

On Dec. 6, 2012, Qualitest voluntarily recalled 101 lots of hydrocodone bitartrate and acetaminophen tablets, stating in its press release, that a small number of tablets from the affected lots may exceed the weight requirement and could exceed the label claim potency requirements for the ingredients hydrocodone bitartrate and acetaminophen. The affected lots, were distributed between Feb. 20 and Nov. 19, 2012, to wholesale distributors and retail pharmacies in the United States.

Hydrocodone bitartrate and acetaminophen are indicated for the treatment of moderate to moderately severe pain. The increased content of hydrocodone could result in more severe or frequent side effects, such as sedation or respiratory depression, especially in elderly patients who have severe kidney or liver impairment, or patients taking interacting medications, e.g., other sedating medication or certain antidepressants. Unintentional administration of a higher dosage of acetaminophen could cause liver damage, particularly in patients on other acetaminophen-containing medications, patients with liver dysfunction, and people who consume more than three alcoholic beverages a day.

The FDA is aware of this recall and additional information can be found on its website.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
33%
Breakthrough designations
17%
Protecting the supply chain
50%
Expedited reviews of drug submissions
0%
More stakeholder involvement
0%
View Results
Jim Miller Outsourcing Outlook Jim Miller Health Systems Raise the Bar on Reimbursing New Drugs
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerThe Mainstreaming of Continuous Flow API Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler Industry Seeks Clearer Standards for Track and Trace
Siegfried Schmitt Ask the Expert Siegfried SchmittData Integrity
Clusters set to benefit from improved funding climate but IP rights are even more critical
Supplier Audit Program Marks Progress
FDA, Drug Companies Struggle with Compassionate Use Requests
USP Faces New Challenges
Report: Pfizer Makes $101 Billion Offer to AstraZeneca
Source: ePT--the Electronic Newsletter of Pharmaceutical Technology,
Click here