FDA-Drug2014-10-01Class II
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.
Alvogen, Inc
Hazard
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.
Sold states
Nationwide
Affected count
8,964 (100 Count) bottles
Manufactured in
10 Bloomfield Ave, Building B, Suite 2, Pine Brook, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1607-2014Don't want to check this manually?
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