Recall: D-0943-2017

Class III - Minor Violations

Class IIIClassification

2017-06-16Initiated

TerminatedStatus

Sandoz IncorporatedFirm

Product

Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC 0781-1487-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540

Reason

Cross Contamination With Other Product: Imipramine

Distribution

Product was distributed throughout the United States

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