D-1115-2017 Class II Terminated
FDA drug recall D-1115-2017 was initiated by C. O. Truxton on April 20, 2017 and is designated Class II. Reason for recall: Labeling: Label Mixup; potentially mislabeled The recall status is terminated (terminated September 11, 2018). Affected quantity: unknown.
Recall Details
- Product Type
- Drugs
- Report Date
- August 30, 2017
- Initiation Date
- April 20, 2017
- Termination Date
- September 11, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- unknown
Product Description
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 Pattern
Nationwide
Code Information
Lot # C0260416A; Exp. 03/18