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.
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.
Lot numbers, UPCs & expiration codes
Lot #: 402794NV, Exp 12/13
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1381-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 7, 2012
- FDA report date
- Jun 20, 2012
- Quantity
- 11,764 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Endo Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1381-2012, exactly as published.
Show all FDA fields
- City
- Chadds Ford
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 61791
- Address
- 100 Endo Blvd
- Code information
- Lot #: 402794NV, Exp 12/13
- Postal code
- 19317
- Report date
- Jun 20, 2012
- Product type
- Drugs
- Recall number
- D-1381-2012
- Classification
- Class III
- Recalling firm
- Endo Pharmaceuticals, Inc.
- Product quantity
- 11,764 bottles
- Termination date
- Jun 21, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- May 7, 2012
- Initial firm notification
- Letter
- Center classification date
- Jun 14, 2012