Drug 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.
D-1607-2014
Product summary
- Firm
- Alvogen, Inc
- Event
- Event 69159
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,964 (100 Count) bottles
- Official record key
drug-enforcement:D-1607-2014
Official wording
Reason: 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.
Code information: NDC #47781-0230-01; Lot # 453289; Exp 08/31/15
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Content Uniformity Specifications