Recalls / Class II
Class IID-1607-2014
Product
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.
- Affected lot / code info
- NDC #47781-0230-01; Lot # 453289; Exp 08/31/15
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.
Recalling firm
- Firm
- Alvogen, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10 Bloomfield Ave, Building B, Suite 2, Pine Brook, New Jersey 07058-9743
Distribution
- Quantity
- 8,964 (100 Count) bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-08-28
- FDA classified
- 2014-09-23
- Posted by FDA
- 2014-10-01
- Terminated
- 2015-04-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1607-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.