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
