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.

Recall Number: D-1445-2014

Firm: Sandoz Inc

Classification: Class III

Status: Terminated

Report Date: 20140730

Initiation Date: 20140711

Termination Date: 20170710

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

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.