Sandoz Incorporated recalls Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( ND…

Recall date

June 16, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0943-2017

FDA classification

Class III

Brand / firm

Sandoz Incorporated

Sold / distributed

Product was distributed throughout the United States

Why it was recalled

Cross Contamination With Other Product: Imipramine

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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