FDA recall D-1445-2014

Product

Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.

Reason for recall

Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-07-11

Report date

2014-07-30

Termination date

2017-07-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1445-2014