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Contact:
Consumer:
1-866-723-2681
Media:
Kevin Wiggins
610-459-7281
FOR IMMEDIATE RELEASE - June 24,
2011 - Endo Pharmaceuticals today issued a voluntary
nationwide consumer level recall of Endocet®
(oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg 100 count
bottles, NDC 60951-712-70, Lot # 402415NV and #402426NV.
One bottle from each lot of Endocet® (oxycodone/acetaminophen,
USP) Tablets, 10 mg/325 mg, Lot # 402415NV and # 402426NV,
NDC 60951-712-70, 100 count bottles, was found to contain
some Endocet® 10 mg/650 mg Tablets, which are identifiable by
their larger size, and different shape and markings. Currently, no
other bottles from the subject lots or any other lots have been
found to erroneously contain Endocet® 10 mg/650 mg Tablets.
No injuries have been reported to date.
Because the recalled bottles may contain incorrect tablets that
have a higher dosage of acetaminophen, consumers may take more than
the intended acetaminophen dose. Unintentional administration of
tablets with increased acetaminophen content may 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 overdosage can potentially cause
severe liver damage.
Consumers who have the affected product should stop using the
product and contact Endo’s agent Stericycle at
1-866-723-2681 for return of the product. If consumers
have any questions as to whether they possess the affected product,
please call the number listed above.
The recall includes the following lots of this product:
- Endocet® (oxycodone/acetaminophen, USP) Tablets, 10 mg /325
mg 100 count bottles, NDC 60951-712-70, Lot # 402415NV, Expiry
01/2014; and
- Endocet® (oxycodone/acetaminophen, USP) Tablets, 10 mg /325
mg 100 count bottles, NDC 60951-712-70,Lot # 402426NV, Expiry
01/2014
This voluntary recall is being made with the knowledge of the
U.S. Food and Drug Administration.
These lots were distributed between April 19, 2011 and May 10,
2011 directly to wholesalers who are located in the following
states: AL, AZ, CA, CO, NY, OH, ND, PR, IL, KY, NH, NJ, LA, NC, MO,
PA, FL and TN. These wholesalers may further distribute to other
retailers and wholesalers nationwide. Lot numbers can be found on
the side of the manufacturer’s bottle.
Endocet® (oxycodone/acetaminophen, USP) 10 mg/325 mg tablets
are 0.6 inches in length, 0.27 inches in width and yellow
capsule-shaped tablets, marked “E712” on one side and
“10/325” on the other. By contrast, Endocet®
(oxycodone/acetaminophen, USP) 10 mg/650 mg tablets are larger (0.7
inches in length, 0.4 inches in width) and yellow oval-shaped
tablets, marked “E797” on one side and
“10”on the other.
Endo is notifying all customers who may have received affected
product and arranging for the return of any affected product.
Consumers with questions may contact Endo’s agent
Stericycle at 1-866-723-2681 during the hours of 8AM
– 8PM EST Monday through Friday and 8AM – 5PM EST
Saturday and Sunday. The phones will be staffed by Stericycle.
Adverse reactions or quality problems experienced with the use
of this product may be reported to FDA’s MedWatch Adverse
Event Reporting program either on line, by regular mail, or by
fax.
Reports of adverse reactions or quality problems can also be
reported to Endo Pharmaceuticals at 1-800-462-3636.
About Endo Pharmaceuticals
Endo Pharmaceuticals is a U.S.-based, specialty healthcare
solutions company, focused on high-value branded products and
specialty generics. Endo is redefining its position in the
healthcare marketplace by anticipating and embracing the evolution
of health decisions based on the need for high-quality and
cost-effective care. We aim to be the premier partner to healthcare
professionals and payment providers, delivering an innovative suite
of complementary diagnostics, drugs, devices and clinical data to
meet the needs of patients in areas such as pain, urology, oncology
and endocrinology. For more information about Endo Pharmaceuticals,
and its wholly owned subsidiaries American Medical Systems, Inc.,
HealthTronics, Inc. and Qualitest Pharmaceuticals, please visit http://www.endo.com/.
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