FDA Drug recall D-1115-2017
Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811, Distrib…
- FDA Drug
- Class II
- terminated
- Published 2017-08-30
On 2017-08-30 the FDA classified a Class II recall of Amitriptyline HCL Tablets, USP 50 mg, 100 count bottles, Rx Only, Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811, Distrib… by C O Truxton, citing labeling: Label Mixup; potentially mislabeled.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1115-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-20 |
| Published | 2017-08-30 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | C O Truxton |
| Distribution | US |
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
Labeling: Label Mixup; potentially mislabeled
Identifiers
| code_info | Lot # C0260416A; Exp. 03/18 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1115-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.