FDA recall D-1381-2012

Product

Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per bottle, Rx only, Manufactured for: Endo Pharmaceuticals Inc., Chadds Ford, PA, By: Novartis, Lincoln, NE 68501; NDC 60951-797-70.

Reason for recall

Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.

Distribution

Nationwide and Puerto Rico

Key facts

Status

Terminated

Initiation date

2012-05-07

Report date

2012-06-20

Termination date

2013-06-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chadds Ford, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1381-2012