Navigation Links
Qualitest Pharmaceuticals Issues Voluntary, Nationwide Recall of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg / 500 mg, NDC 0603-3888-20, 60 Count, Lot Numbers T150G10B, T120J10E and T023M10A and Phenobarbital Tablets, USP 32.4 mg, ND

HUNTSVILLE, Ala., Feb. 5, 2011 /PRNewswire/ -- Qualitest Pharmaceuticals today issued a voluntary nationwide recall of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A, and Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A. An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled with a Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count label, printed with Lot Number T150G10B.  Lots T120J10E and T023M10A used the same stock inventory of labels as Lot T150G10B and are potentially impacted.

As a result of this mix-up patients may unintentionally take Hydrocodone and acetaminophen tablets, instead of the intended dose of Phenobarbital. Unintentional administration of Hydrocodone can lead to serious adverse events including respiratory depression, CNS depression, coma and death, especially in opioid naive patients and patients on other CNS depressants. Unintentional administration of acetaminophen may result in liver toxicity in patients on other acetaminophen containing medications, patients with liver dysfunction, or people who consume more than 3 alcoholic beverages a day. Additionally, missing doses of Phenobarbital could result in loss of seizure control.

No injuries have been reported to date.

Consumers who have affected product should stop using the product and contact Qualitest at 1-800-444-4011 for reimbursement. The lot number can be found on the side of the bottle.

The recall includes the following products:

  • Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count, Lot Numbers T150G10B, T120J10E and T023M10A
  • Phenobarbital Tablets, USP 32.4 mg, NDC 0603-5166-32, 1000 count, Lot Numbers T150G10B, T120J10E and T023M10A

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

These lots were distributed between Sept. 21, 2010 and Dec. 29, 2010 to wholesale and retail pharmacies nationwide (including Puerto Rico).  Lot numbers can be found on the side of the bottle.  Hydrocodone Bitartrate and Acetaminophen Tablets are large (approximately 16.5 mm in length), pink, capsule-shaped tablets, debossed (3600) on one side, and debossed (V) on the reverse side; Phenobarbital Tablets are small (approximately 6.4 mm in diameter), white, round, biconvex, scored tablets, debossed (5012) and (V) on one side and plain on the reverse side. All patients who have filled prescriptions of Phenobarbitol manufactured by Qualitest, are asked to double check the identity of their tablets.

Qualitest is notifying all customers who may have received affected product and arranging for the return of any affected product.

Consumers with questions may contact Qualitest at 1-800-444-4011 for more information.

Adverse reactions or quality problems experienced with the use of this product may be reported to the manufacturer or to FDA's MedWatch Adverse Event Reporting program either on line, by regular mail, or by fax.

Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787

  • Fax: 1-800-FDA-0178

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 Pharmaceuticals (Nasdaq: ENDP), a U.S.-based, specialty healthcare solutions company, focused on high-value branded products and specialty generics (  

SOURCE Qualitest Pharmaceuticals
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Qualitest Pharmaceuticals Selects TrackWise® for Comprehensive Enterprise Quality and Document Management
2. Endo Pharmaceuticals Announces Agreement to Acquire Qualitest Pharmaceuticals for $1.2 Billion
3. Lotus Pharmaceuticals to Expand Construction of Beijing Facility
4. Quercegen Pharmaceuticals LLC Obtains FDA GRAS Notified Status for its QU995™ Quercetin with Purity Greater than 99.5%
5. Onyx Pharmaceuticals Appoints Bill Ringo to Board of Directors
6. AVANIR Pharmaceuticals Announces Fiscal 2011 First Quarter Financial Results
7. Pacira Pharmaceuticals, Inc. Announces Pricing of Its Initial Public Offering
8. Inspiration Biopharmaceuticals Demonstrates Non-Inferiority of IB1001, Its Recombinant Factor IX for Hemophilia B
9. Inovio Pharmaceuticals Dual-Antigen SynCon™ DNA Vaccine for Prostate Cancer Induces Robust Responses in Preclinical Trial
10. Dr. Peter Thompson Joins Anthera Pharmaceuticals Board of Directors
11. Transdel Pharmaceuticals Announces Exploration of Strategic Alternatives
Post Your Comments:
(Date:11/25/2015)... , Nov. 25, 2015 On Tuesday, ... federal bellwether trial against Wright Medical Technology, Inc. ... their Conserve metal-on-metal hip implant device, awarded $11 ... a two week trial and three days of ... hip device was defectively designed and unreasonably dangerous, ...
(Date:11/25/2015)...  ARKRAY USA , Inc., a ... demonstrating the accuracy of its blood glucose meter systems. ... Diabetes and Cardiovascular Disease in Los Angeles ... ® 01 meter and the Assure ® ... to accurately measure glucose levels in blood is essential ...
(Date:11/25/2015)... MELVILLE, N.Y. , Nov. 25, 2015  Henry ... products and services to office-based dental, medical and animal ... Dental (GNYDM) Meeting the Henry Schein ConnectDental® Pavilion ... industry,s broadest array of open solutions designed to help ... Click here for a schedule of ...
Breaking Medicine Technology:
(Date:11/24/2015)... ... November 25, 2015 , ... Genesis Chiropractic Software helps ... creates an agreement between the practice owner and the patient that automatically manages ... and projections. Click here to learn more. , According ...
(Date:11/24/2015)... ... 2015 , ... New patients who wish to seek treatment for missing teeth ... at her Mississauga, ON practice. Dr. Williams has been providing dental service for over ... , Missing teeth can lead to a variety of complications if they are not ...
(Date:11/24/2015)... ... November 24, 2015 , ... ThirdLove, the fast-growing ... a week early, offering 40% off select bras and underwear styles, now through ... both mobile fit technology and the latest fashion, quickly becoming the next generation ...
(Date:11/24/2015)... ... November 24, 2015 , ... DMG Productions announced that they will feature ... quarter 2016 via Discovery Channel. Dates and show times TBA. , Aphria, Inc., is ... the business of producing and supplying medical marijuana pursuant to the Marijuana for Medical ...
(Date:11/24/2015)... Lake City, UT (PRWEB) , ... November 24, 2015 , ... ... to Forbes Magazine. For a business, it is critical that the first impression be ... a business, they are not likely to buy anything or want to return. They ...
Breaking Medicine News(10 mins):