Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

Qualitest Pharmaceuticals Issues Recall of Hydrocodone Bitartrate and Acetaminophen Tablets

By Pharmaceutical Processing | February 7, 2011

Qualitest Pharmaceuticals has 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 naïve 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.

Telephone: 1-800-444-4011

Online: http://www.fda.gov/MedWatch/report.htm9

Regular Mail: Use postage-paid FDA form 3500 available at: http://www.fda.gov/MedWatch/getforms.htm10
Mail to MedWatch 5600 Fishers Lane,
Rockville, MD 20852-9787

Fax: 1-800-FDA-0178

 

Related Articles Read More >

kobayashi pharmaceutical logo
Report: Japan health authorities investigate Kobayashi Pharmaceutical factory after five deaths
Disposable syringe and American currency on black background
PBMs increasingly under fire in drug-pricing battle
Johnson & Johnson logo
Timeline: Navigating Johnson & Johnson’s talc lawsuits and their stock performance impact
pharmaceutical industry. Production line machine conveyor with glass bottles ampoules at factory
5 core trends in drug recalls: An analysis of 2022 and Q1 2023
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE