FDA recall D-1115-2017

C. O. Truxton · Class II · drug

Product

Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811, Distributed by: Truxton, Inc. Bellmawr, NJ 08031, NDC: 0463-6352-10

Reason for recall

Labeling: Label Mixup; potentially mislabeled

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2017-04-20
Report date: 2017-08-30
Termination date: 2018-09-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bellmawr, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1115-2017