Recalls / Class III
Class IIID-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.
- Affected lot / code info
- Lot #: 402794NV, Exp 12/13
Why it was recalled
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.
Recalling firm
- Firm
- Endo Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 Endo Blvd, Chadds Ford, Pennsylvania 19317
Distribution
- Quantity
- 11,764 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2012-05-07
- FDA classified
- 2012-06-14
- Posted by FDA
- 2012-06-20
- Terminated
- 2013-06-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1381-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.