PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: August 30, 2017 Initiated: April 20, 2017 #D-1115-2017

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

Details

Recalling Firm
C. O. Truxton
Units Affected
unknown
Distribution
Nationwide
Location
Bellmawr, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by C. O. Truxton. Units affected: unknown.
Why was this product recalled?
Labeling: Label Mixup; potentially mislabeled
Which agency issued this recall?
This recall was issued by the FDA Drug on August 30, 2017. Severity: Moderate. Recall number: D-1115-2017.