Why it was recalled
Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone component.
Product description
Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only. Manufactured by Norwich Pharmaceuticals Inc., Norwich, NY 13185 USA; Distributed by Alvogen Inc, Pine Brook NJ 07058 USA.
Lot numbers, UPCs & expiration codes
NDC #47781-0230-01; Lot # 453289; Exp 08/31/15
Where it was sold
Nationwide
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-1607-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 28, 2014
- FDA report date
- Oct 1, 2014
- Quantity
- 8,964 (100 Count) bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alvogen, Inc
Original FDA data
Every field from FDA enforcement report D-1607-2014, exactly as published.
Show all FDA fields
- City
- Pine Brook
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 69159
- Address
- 10 Bloomfield Ave
- Address (line 2)
- Building B, Suite 2
- Code information
- NDC #47781-0230-01; Lot # 453289; Exp 08/31/15
- Postal code
- 07058-9743
- Report date
- Oct 1, 2014
- Product type
- Drugs
- Recall number
- D-1607-2014
- Classification
- Class II
- Recalling firm
- Alvogen, Inc
- Product quantity
- 8,964 (100 Count) bottles
- Termination date
- Apr 30, 2015
- Reason for recall
- Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone component.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only. Manufactured by Norwich Pharmaceuticals Inc., Norwich, NY 13185 USA; Distributed by Alvogen Inc, Pine Brook NJ 07058 USA.
- Distribution pattern
- Nationwide
- Recall initiation date
- Aug 28, 2014
- Initial firm notification
- Letter
- Center classification date
- Sep 23, 2014