FDA-Drug2017-07-12Class III

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

Sandoz Incorporated
Hazard

Cross Contamination With Other Product: Imipramine

Sold states
Product was distributed throughout the United States
Affected count
38,234 bottles
Manufactured in
2555 W Midway Blvd, N/A, Broomfield, CO, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0943-2017

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