FDA recall D-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.

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-08-28

Report date

2014-10-01

Termination date

2015-04-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pine Brook, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1607-2014