Recall: D-1445-2014

Class III - Minor Violations

Class IIIClassification

2014-07-11Initiated

TerminatedStatus

Sandoz IncFirm

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

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.