Reported Oct 1, 2014 · Terminated
Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg 100 count bottles Rx Only. Manufactured by Norwich Pharmaceuticals…
Alvogen, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alvogen, Inc · 10 Bloomfield Ave · Pine Brook, NJ · 07058-9743
Is this the product you have?
- 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 codes and dates
NDC #47781-0230-01Lot # 453289Exp 08/31/15
- Amount recalled
- 8,964 (100 Count) bottles
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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