Status
Terminated
Drug Enforcement D-1381-2012
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.
Classification
Class III
Report Date
June 20, 2012
Termination Date
June 21, 2013
Product Information
- Product description
- 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.
- Product quantity
- 11,764 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Endo Pharmaceuticals, Inc.
- Address
-
100 Endo Blvd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1381-2012
- Event ID
- 61791
- Recall initiation date
- May 7, 2012
- Center classification date
- June 14, 2012
- Code info
- Lot #: 402794NV, Exp 12/13
- More code info
- —