Activate Now
 
ProHealth fibromyalgia Vitamin and Natural Supplement Store and Health
Home  |  Log In  |  My Account  |  View Cart  View Your ProHealth Vitamin and Supplement Shopping Cart
800-366-6056  |  Contact Us  |  Help
Facebook Google Plus
Fibromyalgia  Chronic Fatigue Syndrome & M.E.  Lyme Disease  Natural Wellness  Supplement News  Forums  Our Story
Store     Brands   |   A-Z Index   |   Best Sellers   |   New Products   |   Deals & Specials   |   Under $10   |   SmartSavings Club

Trending News

Optic Nerve Thinning Suggests Fibromyalgia is “Neurodegenerative” Disease

Fibromyalgia: The body holding on to past trauma

10 Fast Facts: Fibromyalgia Is Real

Top 10 Mood-Boosting Foods for Fibromyalgia

Ten Tips to Simplify, Lower the Cost, and Optimize CFS and fibromyalgia Treatment

Patient Insights into the Design of Technology to Support a Strengths-Based Approach to Health Care.

3 Genetic Reset Methods Your Doctor Should Prescribe for Fibromyalgia

How to Obtain Relief for Fibromyalgia - Part 1: Complementary and Alternative Therapies

Keep Learning – Even From Bed!

Fibromyalgia Is Correlated with Retinal Nerve Fiber Layer Thinning.

 
Print Page
Email Article

FDA Alert: Recall of Hydrocodone/Acetaminophen 10/500 - Dec. 6, 2012

  [ 1 vote ]   [ Discuss This Article ]
www.ProHealth.com • December 7, 2012


Press Release:

Qualitest Issues Voluntary, Nationwide Recall of 101 Lots of Hydrocodone Bitartrate and Acetaminophen Tablets, Usp 10 Mg/500 Mg Due to the Potential for Oversized Tablets

– Source: FDA Press Release, December 6, 2012

Qualitest, a subsidiary of Endo Health Solutions, (Nasdaq: ENDP) today issued a voluntary nationwide recall for 101 lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. This includes product with the following NDC numbers and lot numbers beginning with the letter “C”.

NDC Number Bottle Count
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

It is possible that a number of tablets from the affected lots may exceed the weight requirement and could exceed the label claim potency requirements for the ingredients of hydrocodone bitartrate and acetaminophen. Hydrocodone bitartrate and acetaminophen 10mg/500 mg tablets are indicated for the relief of moderate to moderately severe pain.

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 acetaminophen dose. Unintentional administration of tablets with increased acetaminophen content could result in liver toxicity, especially in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. The product label warns consumers that acetaminophen overdose can potentially cause severe liver damage, at times resulting in liver transplant or death.

The affected lots, were distributed between Feb. 20, 2012 and Nov. 19, 2012 to wholesale distributors and retail pharmacies nationwide. The lot number can be found on the side of the manufacturer’s bottle. Hydrocodone Bitartrate and Acetaminophen Tablets are approximately 16.51 mm in length, pink, capsule-shaped tablets, with “3600” debossed on one side of the tablet and “V” on the other.

It is very important that consumers do not exceed the maximum daily dose in the prescribing information for this product (no more than 6 tablets per day) and are fully aware of any other prescription or over-the-counter medications they may be taking that contain acetaminophen. If there is any doubt, a consumer should consult with their health care professional.

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.

No injuries have been reported to date.

Consumers who have the affected lots should contact Qualitest at 1-800-444-4011. Consumers who are unsure if they have the affected lot numbers or have any concerns about their product should consult their pharmacy or health care professional.

Pharmacists and wholesalers are asked to check their inventories for the affected lots, segregate any material from the lots, and to contact MedTurn at 1-800-967-5952 for instructions on product return. Pharmacies that received the affected lots will receive a copy of this press release with their recall notification information to be prominently posted in the pharmacy area.

For more information please contact Qualitest at 1-800-444-4011; Monday through Friday between the hours of 8 a.m. and 5 p.m. CST. Reports of adverse reactions or quality problems can also be reported to Qualitest at 1-800-444-4011; Monday through Friday between the hours of 8 a.m. and 5 p.m. CST.

This voluntary recall is being made with the knowledge of the U.S. Food and Drug Administration.

About Qualitest

Founded in 1983, Qualitest provides affordable, high-quality generic pharmaceuticals. Featuring a current portfolio exceeding 600 products, the company has grown significantly since its inception and is now ranked in the top ten among all suppliers of generics, based on total prescriptions filled. Qualitest is a wholly owned subsidiary of Endo Health Solutions (Nasdaq: ENDP), a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics (www.endo.com).




Post a Comment

Featured Products From the ProHealth Store
Energy NADH™ 12.5mg Hydroxocobalamin Extreme™ Guaifenesin FA™

Looking for Vitamins, Herbs and Supplements?
Search the ProHealth Store for Hundreds of Natural Health Products


Article Comments



Be the first to comment on this article!

Post a Comment


 
Natural Pain Relief Supplements

Featured Products

Fibro Freedom™ Fibro Freedom™
Soothes, Strengthens & Revitalizes
FibroSleep™ FibroSleep™
The All-in-One Natural Sleep Aid
Energy NADH™ 12.5mg Energy NADH™ 12.5mg
Improve Energy & Cognitive Function
Guaifenesin FA™ Guaifenesin FA™
Helps the Body Eliminate Excess Calcium and Phosphates
Hydroxocobalamin Extreme™ Hydroxocobalamin Extreme™
The B-12 Your Brain Needs for Detox & Sharpness

Natural Remedies

Three-Step Strategy to Reverse Mitochondrial Aging Three-Step Strategy to Reverse Mitochondrial Aging
Irritable Bowel Syndrome: Unlocking the Secrets of Peppermint, Acacia and Fennel Irritable Bowel Syndrome: Unlocking the Secrets of Peppermint, Acacia and Fennel
Undenatured Type II Collagen - Chicken Soup for Your Joints Undenatured Type II Collagen - Chicken Soup for Your Joints
How Glutathione Can Save Your Life How Glutathione Can Save Your Life
Coenzyme Q10 - The Energy Maker Coenzyme Q10 - The Energy Maker

CONTACT US
ProHealth, Inc.
555 Maple Ave
Carpinteria, CA 93013
(800) 366-6056  |  Email

· Become a Wholesaler
· Vendor Inquiries
· Affiliate Program
SHOP WITH CONFIDENCE
Credit Card Processing
SUBSCRIBE AND SAVE 15% NOW*
Be the first to know about new products, special discounts and the latest health news. *New subscribers only

CONNECT WITH US ProHealth on Facebook  ProHealth on Twitter  ProHealth on Pinterest  ProHealth on Google Plus

© 2016 ProHealth, Inc. All rights reserved. Pain Tracker App  |  Store  |  Customer Service  |  Guarantee  |  Privacy  |  Contact Us  |  Library  |  RSS  |  Site Map