Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01)…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Recalling firm

Sandoz Incorporated

NDC code

0781-1487-01

Origin

CO, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0943-2017

Other Amitriptyline recalls

See all

Class II · Moderate risk Terminated Aug 12, 2019

S-AMITRIPTYLINE 10MG/ML MDV INJ SOLN, 30ML, glass vial, Rx Only, Red Mountain Compounding RX

Reason Lack of Assurance of Sterility

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0198-2020

Class II · Moderate risk Terminated Feb 9, 2018

Amitriptyline HCl USP for prescription compounding , packaged in a) 25 g (NDC 58597-8003-4); b) 100 g (NDC 58597-8003-6); c) 500…

Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…

American Pharmaceutical Ingredients LLC NDC 58597-8003-4 D-0474-2018

Class II · Moderate risk Terminated Apr 20, 2017

Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL…

Reason Labeling: Label Mixup; potentially mislabeled

C. O. Truxton D-1115-2017

Class II · Moderate risk Terminated Mar 25, 2016

All ketamine and amitriptyline Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN…

Reason Lack of Processing Controls

Reliable Rexall-A Compounding Pharmacy D-1126-2016

Class II · Moderate risk Terminated Nov 14, 2014

Amitriptyline HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184…

Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…

Attix Pharmaceuticals D-516-2015