Endocet 325 mg Bottles May Contain Wrong Tablets, Recall Issued

Endo Pharmaceuticals has just issued a nationwide, consumer level recall of <"http://www.yourlawyer.com/practice_areas/defective_drugs">Endocet® tablets, the U.S. Food and Drug Administration (FDA), announced.

Endocet® tablets—an oxycodone/acetaminophen formulation—(USP tablets) involved are distributed as 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 its 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 and 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, toll-free, at 1.866.723.2681 for return of the product and if they have any questions as to whether they possess the affected product. The lines will be manned by Stericycle staff from 8:00 a.m. to 8:00 p.m., Monday through Friday, and 8:00 a.m. to 5:00 p.m. Saturday and Sunday, Eastern Standard Time (EST).

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. The recall includes the following lots:

• 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

These lots were distributed between April 19, 2011 and May 10, 2011 directly to wholesalers who are located in the following states: Alabama, Arizona, California, Colorado, New York, Ohio, North Dakota, Illinois, Kentucky, New Hampshire, New Jersey, Louisiana, North Carolina, Missouri, Pennsylvania, Florida, and Tennessee, as well as Puerto Rico. Wholesalers may further distribute to other retailers and wholesalers nationwide. Lot numbers can be found on the side of the manufacturer’s bottle.

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

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: Online: www.fda.gov/medwatch/report.htm; Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form; or Fax: 1-800-FDA-0178. Reports of adverse reactions or quality problems can also be reported to Endo Pharmaceuticals, toll-free, at 1.800.462.3636.

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