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
D-1115-2017
Product summary
- Firm
- C. O. Truxton
- Event
- Event 77082
- Status
- Terminated
- Classification
- Class II
- Quantity
- unknown
- Official record key
drug-enforcement:D-1115-2017
Official wording
Reason: Labeling: Label Mixup; potentially mislabeled
Code information: Lot # C0260416A; Exp. 03/18
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
mislabeled