Missouriwatcher
Editor, Senior Moderator
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...
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
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...
http://www.fda.gov/Safety/Recalls/ucm260826.htm
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...
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
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...
http://www.fda.gov/Safety/Recalls/ucm260826.htm